Kabs Pharma Pharmaceutical Products

advertisement

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1208

Tacrolimus capsules 1 mg Each hard gelatin capsule contains:

Tacrolimus 1 mg

Approved colours used in the capsule shell

1207

Tacrolimus capsules 0.5 mg Each hard gelatin capsule contains:

Tacrolimus 0.5 mg

1206

Approved colours used in the capsule shell

Magnesium Sulfate Injection USP Each 2 ml contains :

Magnesium Sulphate I.P. 1 gm

(as heptahydrate)

Water for Injection I.P. q.s.

1205

Nitrofurantoin Sustained Each film coated sustained release tablet contains:

Release Tablets Nitrofurantoin I.P. 100 mg

1204 L-Ornithine – L – Aspartate, Each 5 ml contains :

Silymarin & Multivitamin Susp. L-Ornithine L-Aspartate 150 mg

Silymarin 40 mg

Vitamin B6 I.P. 1.5 mg

Vitamin B12 I.P. 5 mcg

Niacinamide I.P. 45 mg

Zinc Gluconate USP

Equivalent to elemental Zinc 2.5 mg

Sodium Selenite USP

Equivalent to Selenium 100 mcg

In a flavoured syrupy base q.s.

1203

Levosulpiride Injection Each ml contains:

Levosulpiride 12.5 mg

Water for Injection I.P. q.s.

1202

R-Ondansetron Injection Each ml contains :

R-Ondansetron Hydrochloride Dihydrate

Equivalent to R-Ondansetron 1 mg

Excipients q.s.

Water for Injection I.P. q.s.

1201 Pepsin & Alpha Amylase Each capsule contains :

Capsules Pepsin IP (1:3000) 12.50 mg

Alpha Amylase IP (1:) 18.75 mg

(Fungal diastase derived from Aspergillus oryzae)

1200 Dexketoprofen Trometamol Each 2 ml contains :

Injection Dexketoprofen Trometamol

Page 1 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Equivalent to Dexketoprofen 50 mg

Absolute Alcohol I.P. 5.0 % v/v

Water for Injection I.P. q.s.

1199

Paracetamol, Phenylephrine Each uncoated tablet contains:

Hydrochloride, Chlorpheniramine Paracetamol IP……………..………….… 500 mg

Maleate & Caffeine Tablets Phenylephrine Hydrochloride IP….…......10 mg

Chlorpheniramine Maleate IP…………….2 mg

Caffeine (Anhydrous) IP…………….……30 mg

Excipients………………..……………..……..q.s.

Colour: Ponceau 4R

1198 Multivitamin , Minerals & Lysine Each 5 ml contains :

Syrup Pyridoxine Hydrochloride IP 3 mg

Cyanocobalamin IP 15 mcg

Folic Acid IP 1 mg

Nicotinamide IP 45 mg

Ferric Ammonium Citrate IP 24.4 mg

Equivalent to Elemental Iron 5.0 mg

Chromium Chloride USP 100 mcg

Sodium Selenite BP

Eq. to Elemental Selenium 55 mcg

L-Lysine Hydrochloride USP 30 mg

In a flavoured syrupy base q.s.

Colours : Caramel IP & Ponceau 4R

1197 Buclizine Hydrochloride Syrup Each 5 ml contains :

Buclizine Hydrochloride IP 6 mg

In a flavoured syrupy base

Colours : Carmoisine & Sunset Yellow FCF

1196 Buclizine Hydrochloride tablets Each uncoated tablet contains :

Buclizine Hydrochloride IP 25 mg

Excipients q.s.

1195 Misoprostol Tablets Each uncoated tablet contains:

Misoprostol BP 600 mcg

1194 Sibutramine Hydrochloride Each hard gelatin capsule contains:

Monohydrate 15 mg Capsules Sibutramine Hydrochloride Monohydrate 15 mg

1193 Pyridoxine HCl, Mecobalamin, & Each 5 ml contains :

Lysine Hydrochloride Syrup Pyridoxine Hydrochloride I.P. 3 mg

Page 2 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Mecobalamin 500 mcg

Lysine Hydrochloride B.P. 150 mg

Colour : Caramel IP

1192 Pyridoxine HCl , Mecobalamin & Each film coated tablet contains :

Nicotinamide tablets Pyridoxine Hydrochloride I.P. 3 mg

Mecobalamin 1000 mcg

Nicotinamide I.P. 45 mg

Colours : Red Oxide of Iron & Titanium Dioxide IP

1191 Pyridoxine HCl , Mecobalamin & Each film coated tablet contains :

Nicotinamide tablets Pyridoxine Hydrochloride I.P. 3 mg

Mecobalamin 500 mcg

Nicotinamide I.P. 45 mg

Colours :Erythrosine & Titanium Dioxide IP

1190 Paracetamol , Phenylephrine Each 5 ml (teaspoonful) contains :

Hydrochloride, Chloropheniramine Paracetamol I.P. 125 mg

Maleate, Sodium Citrate & Menthol Phenylephrine Hydrochloride I.P. 5 mg

Syrup Chlorpheniramine Maleate I.P. 1 mg

Sodium Citrate I.P. 60 mg

Menthol I.P. 1 mg

1189 Artemether & Lumefantrine Dry Each 5 ml reconstituted suspension contains:

Syrup Arteimether I.P. 20 mg

Lumefantrine 120 mg

Flavoured base q.s.

Excepients q.s.

1188 Pioglitazone & Metformin Each uncoated bilayered tablet contains :

Hydrochloride (ER) tablets Pioglitazone Hydrochloride I.P.

Equivalent to Pioglitazone 15 mg

Metformin Hydrochloride I.P. 500 mg

(in extended release form)

Colour : Quinoline Yellow

1187 Torsemide & Spironolactone Tablets Each uncoated tablet contains:

Torsemide USP 5 mg

Spironolactone IP 50 mg

1186 Torsemide & Spironolactone Tablets Each uncoated tablet contains:

Torsemide USP 10 mg

Spironolactone IP 50 mg

1185 Clomiphene Citrate Tablets IP 50 mg Each uncoated tablet contains :

Page 3 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Clomiphene Citrate IP 50 mg

Excipients q.s.

1184 Clomiphene Citrate Tablets IP 25 mg Each uncoated tablet contains :

Clomiphene Citrate IP 25 mg

Excipients q.s.

1183 Levofloxacin Oral Syrup Each 5 ml contains :

Levofloxacin Hemihydrate I.P.

Equivalent to Levofloxacin 125 mg

Flavoured syrup base q.s.

1182 Orphenadrine Citrate Tablets Each uncoated tablet contains:

Orphenadrine Citrate B.P. 100 mg

1181 Telmisartan & Amlodipine Tablets Each uncoated bilayered tablet contains :

Telmisartan BP 40 mg

Amlodipine Besilate IP

Equivalent to Amlodipine 2.5 mg

1180

Pioglitazone & Metformin Each uncoated bilayered tablet contains :

Hydrochloride (ER) tablets Pioglitazone Hydrochloride I.P.

Equivalent to Pioglitazone 15 mg

Metformin Hydrochloride I.P. 500 mg

(in extended release form)

Colour : Quinoline Yellow

1179 GLA, Methylcobalamin , ALA, Zinc Each hard gelatin capsule contains:

Selenium & Chromium capsuels Gamma Linolenic Acid (10 %) 100 mg

Methylcobalamin 750 mcg

Alpha Lipoinc Acid USP 100 mg

Zinc Sulphate Monohydrate USP

Eq. to Elemental Zinc 15 mg

Selenium Dioxide

Eq. to Selenium 50 mg

Chromium Picolinate USP

Equivalent to Chromium 200 mcg

1178 SIMETHICONE ORAL SUSPENSION Each 100 ml contains :

Simethicone 1 % w/w

(As Simethicone Emulsion USP )

Excipients q.s.

1177 Olmesartan Medoxomil & Each film coated tablet contains:

Hydrochlorothiazide tablets Olmesartan Medoxomil 20 mg

Hydrochlorothiazide IP 12.5 mg

Page 4 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colours :Yellow Oxide Of Iron & Titanium Dioxide IP

1176 Olmesartan Medoxomil & Each film coated tablet contains:

Hydrochlorothiazide tablets Olmesartan Medoxomil 40 mg

Hydrochlorothiazide IP 12.5 mg

Colours :Yellow Oxide Of Iron & Titanium Dioxide IP

1175 Hyoscine Butylbromide Tablets IP Each film coated tablet contains:

Hyoscine Butylbromide IP 10 mg

Colour : Titanium Dioxide IP

1174 Lornoxicam Mouth Dissolving tablets Each uncoated mouth dissolving tablet contains :

4 mg Lornoxicam 4 mg

Colour : Quinoline Yellow

1173 Lornoxicam Mouth Dissolving tablets Each uncoated mouth dissolving tablet contains :

8 mg Lornoxicam 8 mg

Colour : Quinoline Yellow

1172 Granisetron Injection Each ml contains :

Granisetron Hydrochloride B.P.

Equivalent to Granisetron 1 mg

Water for Injection I.P. q.s.

1171 Glucosamin & Methyl Sulfonul Each film coated tablet contains:- DCG (I) +

Methane tablets Glucosamine Sulphate

Potassium Chloride USP 750mg

Methyl Sulfonyl Methane 250mg

Diacerein 50mg

Colour: Quinoline yellow

1170 L-Carnitine L- Tartrate Tablets Each film coated tablet contains:

L-Carnitine L- Tartrate 725 mg

Equivalent to L-Carnitine 500 mg

1169 Cholecalciferol Granules Each sachet of 1 gm contains :

Cholecalciferol I.P. 60,000 I.U.

Excipients q.s.

1168 L-Ornithine - L- Aspartate Granules Each 5g sachet contains:

L-Ornithine - L- Aspartate : 3 g

Flavoured base

Colour : Sunset Yellow FCF

1167 Sibutramine Hydrochloride Capsules Each hard gelatin capsule contains :

Sibutramine Hydrochloride Monohydrate 10 mg

1166 Telmisartan & Amlodipine Tablets Each uncoated bilayered tablet contains :

Telmisartan B.P. 40 mg

Amlodipine Besilate I.P.

Equivalent to Amlodipine 5 mg

Colour : Red Oxide of Iron

Page 5 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1165 Methylcobalamin , Vitamin B6 Each ml contains :

& Nicotinamide Injection Methylcobalamin 500 mcg

Pyridoxine Hydrochloride I.P. 50 mg

Nicotinamide I.P. 50 mg

Benzyl Alcohol I.P. 2 % w/v

(as preservative)

Water for Injection I.P. q.s

1164 Granisetron Dispersible Tablets Each uncoated dispersible tablet contains :

Granisetron Hydrochloride B.P.

Equivalent to Granisetron 1 mg

1163 Granisetron Syrup Each 5 ml contains :

Granisetron Hydrochloride B.P.

Equivalent to Granisetron 1 mg

Flavoured syrupy base q.s.

Colour : Sunset Yellow FCF

1162 Piracetam Injection Each ml contains :

Piracetam B.P. 200 mg

Water for Injection I.P. q.s.

1161 Quetiapine Fumarate Tablets 50 mg Each film coated tablet contains:

Quetiapine Fumarate

Equivalent to Quetiapine 25 mg

Colour: Titanium Dioxide I.P.

Quetiapine Fumarate Sustained

1160 Released Tablets Each film coated sustained release tablet contains:

Quetiapine Fumarate

Equivalent to Quetiapine 50 mg

Colour: Titanium Dioxide I.P.

1159 Quetiapine Fumarate Sustained Each film coated sustained release tablet contains:

Release tablets 100/ 200 / 300/ Quetiapine Fumarate

400 mg Equivalent to Quetiapine 100/200/300/400 mg

Colour: Titanium Dioxide I.P.

1158 Loxapine Liquid Concentrate Each ml contains :

Loxapine Hydrochloride

Equivalent to Loxapine 25 mg

In a Palatable base q.s.

1157 Biotin Tablets 10 mg Each film coated tablet contains:

Biotin B.P. 10 mg

Excipients q.s.

1156 Zinc Sulfate & Folic Acid Tablets Each film coated tablet contains :

Zinc Sulfate Monohydrate USP 55 mg Page 6 of 252

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Folic Acid I.P. 5 mg

Colours: Iron Oxide Yellow & Titanium Dioxide I.P.

1155 Artemether & Lumefantrine Tablets Each uncoated tablet contains

Artemether I.P. 80 mg

Lumefantrine 480 mg

1154 Artemether & Lumefantrine Tablets Each uncoated dispersible tablet contains

Artemether I.P. 40 mg

Lumefantrine 240 mg

1153 Artemether & Lumefantrine Tablets Each uncoated dispersible tablet contains

Artemether I.P. 20 mg

Lumefantrine 120 mg

1152 Kit tablets of Mifepristone & Misoprostol Each kit contains :

A. One Mifepristone Tablets

Each uncoated tablet contains :

Mifepristone 200 mg

B. Four Misoprostol Tablets

Each uncoated tablet contains:

Misoprostol B.P. 200 mcg

1151 Desloratadine Tablets 5 mg Each film coated tablet contains :

Desloratadine 5 mg

Excipients q.s.

Colours : Lake of Indigo Carmine & Titanium Dioxide I.P.

1150 Nimesulide & Paracetamol Tablets Each uncoated tablet contains:

Nimesulide B.P. 200 mg

Paracetamol I.P. 500 mg

Excipients q.s.

1149 Levofloxacin & Ornidazole Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate I.P.

Equivalent to Levofloxacin 250 mg

Ornidazole I.P. 500 mg

Excipients q.s.

1148 Tenofovir and Emtricitabine Tablets I.P. Each film coated tablet contains :

Emtricitabine I.P. 200 mg

Tenofovir Disoproxil Fumarate I.P. 300 mg

1147 Paracetamol & Domperidone Tablets Each uncoated tablet contains :

Paracetamol I.P. 500 mg

Domperidone Maleate I.P.

Equivalent to Domperidone 20 mg

1146 Escitalopram Oxalate & Each film coated tablet contains : Page 7 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Clonazepam Tablets Escitalopram Oxalate

Equivalent to Escitalopram 10 mg

Clonazepam I.P. 0.25 mg

1145 Codeine Phosphate & Chlorpheniramine Each 5 ml contains:

Codeine Phosphate I.P. 10 mg

Chlorpheniramine Maleate I.P. 4 mg

In a pleasantly flavoured syrupy base

1144 Adenosine Injection USP Each ml contains :

Adenosine USP 3 mg

Sodium Chloride I.P. 9 mg

Water for injection I.P. q.s.

1143 Montelukast & Levocetirizine Tablets Each uncoated dispersible tablet contains : DCG (I) +

Montelukast Sodium

Equivalent to Montelukast 4 mg

Levocetirizine Hydrochloride I.P. 2.5 mg

Excipients

1142 FLORA – SB SACHETS Each Sachet (1 gm) contains:

Lactobacillus acidophilus 0.40 billion

Lactobacillus rhamnosus 0.40 billion

Bifidobacterium longum 0.40 billion

Bifidobacterium bifidum 0.40 billion

Saccharomyces boulardii 0.05 billion

Fructo oligo saccharides 100 mg

1141 Racecadotril Sachets Each sachet (1g) contains :

Racecadotril 15 mg

1140 Esomeprazole Tablets Each film coated tablet contains :

(with sodium bicarbonate as buffer) Esomeprazole Magnesium I.P

Equivalent to Esomeprazole 40 mg

Excipients q.s.

1139 Rabeprazole Tablets Each film coated tablet contains :

(with sodium bicarbonate as buffer) Rabeprazole Sodium I.P. 20 mg

Excipients q.s.

Colours : Red oxide of Iron & Titanium Dioxide I.P

Pantoprazole Tablets

(with sodium bicarbonate as buffer)

Telmisartan & Hydrochlorothiazide

1138 Tablets Each film coated tablet contains :

Telmisartan B.P. 40 mg

Hydrochlorothiazide I.P. 12.5 mg

Excipients q.s.

Page 8 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Tartrazine Yellow Lake

1137 Amlodipine & Metoprolol Tablets Each film coated tablet contains:

Amlodipine Besilate I.P.

Equivalent to Amlodipine 5 mg

Metoprolol Succinate USP

Equivalent to Metoprolol Tartrate 50 mg

(as extended release form)

1136 Serratiopeptidase & Nimesulide Tablets Each film coated tablet contains:

Serratiopeptidase 15 mg

(eq. to enzymatic activity 30,000 units)

(as enteric coated granules)

Nimesulide B.P. 100 mg

Serratiopeptidase & Diclofenac

1135 Potassium & Paracetamol Tablets Each film coated tablet contains:

Serratiopeptidase 15 mg

(eq. to enzymatic activity 30,000 units)

(as enteric coated granules)

Diclofenac Potassium B.P. 50 mg

Paracetamol I.P. 500 mg

Nimesulide, Paracetamol & Tizanidine

1134 Tablets Each uncoated tablet contains:

Nimesulide B.P. 100 mg

Paracetamol I.P. 325 mg

Tizanidine Hydrochloride I.P.

Equivalent to Tizanidine 2 mg

(Beta cyclodextrin as excipient)

Codeine Phosphate, Buclizine HCl &

1133 Paracetamol Tablets Each uncoated tablet contains :

Codeine Phosphate I.P. 8 mg

Buclizine Hydrochloride B.P. 6.25 mg

Paracetamol I.P. 500 mg

1132

Trypsin-Chymotrypsin with Dicolofenac

Potassium Each film coated tablet contains :

1,00,000 Armour units of Enzymatic Activity (Supplied by a purified concentrate which has specific Trypsin and

Chymotrypsin activity in a ratio of approximately six to one)

(enteric coated)

Diclofenac Potassium B.P. 50 mg

(Immediate release) Page 9 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1131 Ivermectin & Albendazole Susp. Each 5 ml contains:

Colour : Titanium Dioxide I.P.

Ivermectin B.P. 1.5 mg

Albendazole I.P. 200 mg

In a palatable base

1130 Ivermectin Dispersible Tablets 6 mg Each uncoated dispersible tablet contains :

Ivermectin B.P. 6 mg

Excipients q.s.

1129 Ivermectin Dispersible Tablets 12 mg Each uncoated dispersible tablet contains :

Ivermectin B.P. 12 mg

Excipients q.s.

Colour : Erythrosine

Ivermectin & Albendazole Chewable

1128 Tablets Each uncoated chewable tablet contains:

Ivermectin B.P. 6 mg

Albendazole I.P. 400 mg

Excipients q.s.

Colour : Tartrazine

1127 Biotin & Folic Acid Tablets Each film coated tablet contains :

Biotin B.P. 5.0 mg

Folic Acid I.P. 5.0 mg

Excipients q.s.

1126 Quinine Dihydrochloride Injection IP Each ml contains :

1125 ESSVIT SYRUP

Quinine Dihydrochloride I.P. 300 mg

Water for Injection I.P. q.s.

Each 5 ml contains :

Biotin B.P. 2.5 mg

In a palatable base

Colour : Caramel I.P.

1124 Terbinafine Tablets Each uncoated tablet contains:

Terbinafine Hydrochloride B.P.

Equivalent to Terbinafine 250 mg

Excipients q.s.

1123 Isotretinoin Capsules USP Each hard gelatin capsule contains :

Isotretinoin USP 10 mg

Approved colours used in capsule shell

Diclofenac Potassium & Metaxalone

1122 Tablets Each uncoated tablet contains :

Diclofenac Potassium B.P. 50 mg

Metaxalone 400 mg

Page 10 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1121 Glimepiride & Metformin Each uncoated bilayered tablet contains :

Hydrochloride (SR) Tablets Glimepiride U.S.P. 1 mg

Metformin Hydrochloride I.P. 1000 mg

(in sustained release form)

1120 Glimepiride & Metformin Each uncoated bilayered tablet contains :

Hydrochloride (SR) Tablets Glimepiride U.S.P. 2 mg

Metformin Hydrochloride I.P. 1000 mg

(in sustained release form)

1119 Aceclofenac & Tramadol Tablets Each film coated tablet contains :

Aceclofenac I.P. 100 mg

Tramadol Hydrochloride B.P. 37.5 mg

Excipients q.s

1118 Tadalafil Tablets 20 mg Each film coated tablet contains:-

Tadalafil 20 mg

Excipients q.s.

Thiocolchicoside & Diclofenac Sodium

1117 Capsules Each hard gelatin capsule contains :

Thiocolchicoside 4 mg

Diclofenac Sodium I.P. 50 mg

(as enteric coated tablet

Colours: Sunset Yellow & Titanium Dioxide I.P.)

1116

Thiocolchicoside & Diclofenac Sodium

Capsules Each hard gelatin capsule contains :

Thiocolchicoside 8 mg

Diclofenac Sodium I.P. 50 mg

(as enteric coated tablet

Colours: Sunset Yellow & Titanium Dioxide I.P.)

Tamsulosin Hydrochloride (SR) &

1115 Dutasteride Tablets Each film coated tablet contains :

Tamsulosin Hydrochloride I.P. 0.4 mg

( as Sustained Release)

Dutasteride 0.5 mg

1114 Glimepiride & Metformin Each uncoated bilayered tablet contains :

Hydrochloride (SR) Tablets Glimepiride U.S.P. 1 mg

Metformin Hydrochloride I.P. 850 mg

(in sustained release form)

1113 Glimepiride & Metformin Each uncoated bilayered tablet contains :

Hydrochloride (SR) Tablets Glimepiride U.S.P. 2 mg

Metformin Hydrochloride I.P. 850 mg

(in sustained release form)

Page 11 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1112

Methylcobalamin, Pyridoxine HCl &

Nicotinamide Injection Each 2 ml ampoule contains :

Methylcobalamin 1500 mcg

Pyridoxine Hydrochloride I.P. 100 mg

Nicotinamide I.P. 100 mg

Benzyl Alcohol I.P. 2 % v/v

(as preservative)

1111 Sterile Amiodarone Concentrate BP Each ml contains :

Amiodarone Hydrochloride B.P. 50 mg

Benzyl Alcohol I.P. 2 % v/v

(as preservative)

Water for injection I.P. q.s.

Contains Absolute Alcohol I.P. 20 % v/v

1099 Nitrofurantoin Sustained Release tablets Each film coated sustained release tablet contains:

Nitrofurantoin I.P. 100 mg

Colour : Titanium Dioxide I.P.

1098

S (-) Amlodipine and Telmisartan

Tablets Each uncoated tablet contains:

S (-) Amlodipine Besilate

Equivalent to S (-) Amlodipine 2.5 mg

Telmisartan B.P. 40 mg

S (-) Amlodipine and Telmisartan

1097 Tablets Each uncoated tablet contains:

1096

S (-) Amlodipine Besilate

Equivalent to S (-) Amlodipine 5 mg

Telmisartan B.P. 40 mg

Nimesulide, Loratadine, Ambroxol HCl,

Phenylephrine (SR) Tablets Each uncoated bilayered tablet contains :

Nimesulide BP 100 mg

Loratadine USP 5 mg

Ambroxol Hydrochloride IP 30 mg

Phenylephrine Hydrochloride IP 20 mg

(In Sustained Release Form)

1095 Pioglitazone Tablets IP 15 mg Each film coated tablet contains :

Pioglitazone Hydrochloride I.P.

Equivalent to Pioglitazone 15 mg

Excipients q.s.

Propylene Glycol IP 30% v/v

Water for Injection IP q.s.

Page 12 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1094 Pioglitazone Tablets IP 30 mg Each film coated tablet contains :

Pioglitazone Hydrochloride I.P.

Equivalent to Pioglitazone 30 mg

Excipients q.s.

1093 Glimepiride 1 mg, Pioglitazone 15mg + Each uncoated bilayered tablet contains :

Glimepiride U.S.P. 1 mg

Pioglitazone Hydrochloride I.P.

Equivalent to Pioglitazone 15 mg

Metformin Hydrochloride I.P. 500 mg

(in extended release form)

1092 Glimepiride 2 mg, Pioglitazone 15mg + Each uncoated bilayered tablet contains :

Glimepiride U.S.P. 2 mg

Pioglitazone Hydrochloride I.P.

Equivalent to Pioglitazone 15 mg

Metformin Hydrochloride I.P. 500 mg

(in extended release form)

1091 R-Ondansetron Hydrochloride Each dispersible tablet contains:

Dihydrate Dispersible Tablets R-Ondansetron Hydrochloride Dihydrate

Eq. to R-Ondansetron 2mg

1090 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) +

Acid, Folic Acid & Vit. B6 Caps Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Folic Acid IP 1.5mg

Pyridoxine Hydrochloride IP 3mg

(Containing Mecobalamin and folic acid as film coated tablets)

Colour:Iron Oxide red &Titanium Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

Approved colours used in capsule shell.

1089 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) +

Acid, Folic Acid & Vit. B6 Caps Methylcobalamin 500mcg

Alpha Lipoic Acid USP 100mg

Folic Acid IP 1.5mg

Pyridoxine Hydrochloride IP 3mg

(Containing Mecobalamin and folic acid as film coated tablets)

Colour:Iron Oxide red &Titanium Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

Approved colours used in capsule shell.

Page 13 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1088 Iron (III) Hydroxide Polymaltose Each hard gelatin capsule contains:

Complex & Folic Acid Capsules Iron (III) Hydroxide Polymaltose Complex eq. to elemental Iron 100mg

Folic Acid IP 550mg

Appropriate overages of vitamin added to compenstate for loss on storage.

Approved colours used in capsule shell.

1087 Iron (III) Hydroxide Polymaltose Each uncoated chewable tablet contains: complex & Folic Acid Tablets Iron (III) Hydroxide Polymaltose Complex eq. to elemental Iron 100mg

Folic Acid IP 3500mg

Appropriate overages of vitamin added to compenstate for loss on storage.

1086 Calcium Citrate Malate & Each film coated tablet contains:

Vitamin D3 Tablets Calcium Citrate Malate eq. to elemental Calcium 250mg

Vitamin D3 IP 100 IU

(as stabilized vitamin D3) colour: Titanium Dioxide IP

1085 Calcium Citrate Malate & Each film coated tablet contains:

Vitamin D3 Tablets Calcium Citrate Malate eq. to elemental Calcium 250mg

Vitamin D3 IP 125 IU

(as stabilized vitamin D3) colour: Titanium Dioxide IP

1084 Calcitriol, Calcium Citrate Each film coated tablet contains:

Malate & Zinc Sulfate Tablets Calcitriol BP 0.25mcg

Calcium Citrate Malate eq. to elemental calcium 250mg

Zinc Sulfate Monohydrate USP eq. to elemental zinc 7.5mg

1082 Tramadol Hydrochloride Injection Each ml contains:

Colour: Titanium Dioxide IP

Tramadol Hydrochloride BP 50mg

1081 Tramadol Hydrochloride Injection Each ml contains:

Water for Injection IP q.s

Tramadol Hydrochloride BP 100mg

Water for Injection IP q.s

1080 Theophylline & Pyridoxine HCl Each uncoated controlled release tablet

Controlled Release Tablets contains:

Theophylline Anhydrous IP 400mg Page 14 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Pyridoxine Hydrochloride IP 25mg

1079 Azithromycin & sustained release Each film coated bilayered tablet contains:

Ambroxol Tablets Azithromycin (anhydrous) IP 500mg

Ambroxol Hydrochloride IP 75mg

(In sustained release form)

Excipients q.s.

Colour: Lake of Erythrosine

1078 Azithromycin & sustained release Each film coated bilayered tablet contains: DCG (I) +

Ambroxol Tablets Azithromycin (anhydrous) IP 250mg

Ambroxol Hydrochloride IP 75mg

(In sustained release form)

Excipients q.s.

Colour: Lake of Erythrosine

1077 Mecobalamin with Vitamins Tabs Each film coated tablet contains: DCG (I) +

Thiamine Mononitrate IP 10mg

Pyridoxine Hydrochloride IP 3mg

Mecobalamin 1000mcg

Nicotinamide IP 45mg

Calcium Pantothenate IP 50mg

Colour: Iron Oxide Red

Appropriate overages added to compensate the loss on storage.

1076 Pregabalin & Mecobalamin Caps Each hard gelatin capsule contains: DCG (I) +

Pregabalin 150mg

Mecobalamin 750mcg

(as film coated tablet)

Excipients q.s.

Colour: Ponceau 4R

Approved colours used in capsule shell.

Appropriate overages added to compensate the loss on storage.

1075 Pregabalin & Mecobalamin Caps Each hard gelatin capsule contains: DCG (I) +

Pregabalin 75mg

Mecobalamin 750mcg

(as film coated tablet)

Excipients q.s.

Colour: Ponceau 4R

Approved colours used in capsule shell.

Appropriate overages added to compensate the loss on storage.

1074 Gabapentin, Mecobalamin & Each film coated tablet contains: DCG (I) + Page 15 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Alpha Lipoic Acid Tablets Gabapentin USP 300mg

Mecobalamin 750mcg

Alpha Lipoic Acid USP 100mg colour: Sunset yellow

Appropriate overages added to compensate the loss on storage.

1073 Mecobalamin with Vitamins Tabs Each film coated tablet contains: DCG (I) +

Thiamine Mononitrate IP 10mg

Pyridoxine Hydrochloride IP 3mg

Mecobalamin 1000mcg

Nicotinamide IP 45mg

Calcium Pantothenate IP 50mg

Colour: Iron Oxide Red

Appropriate overages added to compensate the loss on storage.

1072 Injection of Vit. B1, B6, Each 2ml contains:

Methylcobalamin, Niacinamide & Thiamine Mononitrate IP 100mg

D-Panthenol Pyridoxine Hydrochloride IP 100mg

Methylcobalamin 1000mcg

Niacinamide IP 100mg

D-Penthenol IP 50mg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1071 Injection of Vit. B1, B6, Each 2ml contains:

Methylcobalamin, Niacinamide & Thiamine Mononitrate IP 100mg

D-Panthenol Pyridoxine Hydrochloride IP 100mg

Methylcobalamin 500mcg

Niacinamide IP 100mg

D-Penthenol IP 50mg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1070 Vitamin C, Mecobalamin, Folic Each 1.5ml (Part-I) contains:- DCG (I) +

Acid, & Niacinamide Injection Vitamin C IP 150mg

Water for Injection IP q.s

Each 1ml contains (Part-2) contains:

Mecobalamin 1500mcg

Folic Acid IP 0.7mg

Niacinamide IP 12.0mg

Water for Injection IP q.s

Page 16 of 252

DCG (I) +

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1069 Pyridoxine Hydrochloride, Each hard gelatin capsule contains: DCG (I) +

Mecobalamin, Benfothiamine, Pyridoxine Hydrochloride IP 40mg

Inositol & Alpha Lipoic Acid Caps Mecobalamin 1000mcg

Benfothiamine 100mg

Inositol 100mg

Alpha Lipoic Acid USP 100mg

Approved colours used in capsule shell.

Appropriate overages added to compensate the loss on storage.

1068 Pyridoxine Hydrochloride, Each hard gelatin capsule contains: DCG (I) +

Mecobalamin, Benfothiamine, Pyridoxine Hydrochloride IP 40mg

Inositol & Alpha Lipoic Acid Caps Mecobalamin 1000mcg

Benfothiamine 100mg

Inositol 100mg

Alpha Lipoic Acid USP 100mg

Approved colours used in capsule shell.

Appropriate overages added to compensate the loss on storage.

1067 Pyridoxine Hydrochloride, Each film coated tablet contains: DCG (I) +

Benfothiamine, Mecobalamin & Pyridoxine Hydrochloride IP 40mg folic Acid Tablets Benfothiamine 100mg

Mecobalamin 1000mcg

Folic Acid IP 1.5mg

Colour: Yellow Oxide or Iron

Appropriate overages added to compensate the loss on storage.

1066 Pyridoxine Hydrochloride, Each film coated tablet contains: DCG (I) +

Benfothiamine, Mecobalamin & Pyridoxine Hydrochloride IP 40mg folic Acid Tablets Benfothiamine 100mg

Mecobalamin 1000mcg

Folic Acid IP 1.5mg

Colour: Yellow Oxide or Iron

Appropriate overages added to compensate the loss on storage.

1065 L-Ornithine L-Aspartate, Each 5ml contains:

Nicotinamide, Riboflavin Sodium L-Ornithine L-Aspartate 250mg

Phosphate Syrup Nicotinamide BP 20mg

Riboflavin Sodium Phosphate BP 1mg flavoured syrup base q.s.

Prophylactic Vitamin

1064 a-ß -Arteether Injection Each 2ml contains: Page 17 of 252 NA

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS a-ß-Arteether 150mg

Arachis Oil IP q.s

1063 Serratiopeptidase, diclofenac Each film coated tablet contains: NA

Potassium, Paracetamol Tablets Serratiopeptidase 10mg

(Eq. to 20,000 units of serratiopeptidase)

(as enteric coated granules)

Diclofenac Potassium BP 50mg

Paracetamol IP 325mg colour: Sunset yellow FCF

1062 R-Ondansetron Injection Each ml contains:

R-Ondansetron Hydrochloride Dihydrate eq. to Ondansetron 1mg

Excipients q.s.

Water for Injection q.s

1061 Carbonyl Iron, folic Acid, Vitamin Each hard gelatin capsule contains:

B12 & Zinc Sulphate Capsules Carbonyl Iron

Eq. to elemental Iron 100mg folic Acid IP 750mcg

Vitamin B12 IP 5mcg

Zinc Sulphate Monohydrate USP

Eq. to Zinc 22.5mg

Approved colours used in capsule shell.

Appropriate overages of vitamins added to compensate the loss on storage.

1060 Methylcobalamin, Alpha Lipoic Each capsule contains: folic Acid Tablets Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride IP 3mg

Folic Acid IP 1.5mg

(Containing Mecobalamin and folic acid as film coated tablets)

1059 Serratiopeptidase & Nimesulide Each film coated tablet contains:

Tablets Serratiopeptidase 15mg

(Eq. to enzymatic activity 30,000 units)

(as enteric coated granules)

Nimesulide BP 100mg

Colour: Red Oxide Iron & Titanium

Dioxide B.P

1058 Serratiopeptidase, diclofenac Each film coated tablet contains:

Potassium, Paracetamol Tablets Serratiopeptidase 15mg

(Eq. to enzymatic activity 30,000 units) Page 18 of 252

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

(as enteric coated granules)

Diclofenac Potassium BP 50mg

Paracetamol IP 500mg

Colour: Lake of Sunset yellow FCF &

Titanium Dioxide IP

1057 Aceclofenac, Serratiopeptidase & Each film coated tablet contains:

Paracetamol Tablets Aceclofenac IP 100mg

Paracetamol IP 325mg

Serratiopeptidase 15mg

(Eq. to enzymatic activity 30,000 units)

(as enteric coated granules)

Colour: Red Oxide Iron & Titanium

Dioxide I.P

1056 Serratiopeptidase Tablets Each enteric coated tablet contains:

Serratiopeptidase 10mg

(Eq. to enzymatic activity 30,000 units)

(as enteric coated granules)

Colour: Lake of Indigocarmine &

Titanium Dioxide IP

1055 Aceclofenac, Paracetamol & Each film coated tablet contains:

Serratiopeptidase Tablets Aceclofenac IP 100mg

Paracetamol IP 500mg

Serratiopeptidase 15mg

(eq. to enteric coated granules)

Excipients q.s.

Colour: Lake of Sunset yellow FCF

1054 Methylcobalamin Injection Each ml contains:

Methylcobalamin 500mcg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1053 Biotin Tablets 10mg Each film coated tablet contains:

Biotin BP 10mg

Excipients q.s.

Colour: Titanium Dioxide IP

1052 Methylcobalamin Tablets Each film coated tablet contains:

Methylcobalamin 500mcg

Colour: Ponceau 4R

1051 Methylcobalamin Injection Each ml contains:-

Methycobalamin 500mcg

Benzyl Alcohol IP 2% w/v Page 19 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

(as preservative)

Water for Injection IP q.s

1050 Pregabalin & Mecobalamin Caps Each hard gelatin capsule contains: DCG (I) +

Pregabalin 75mg

Methylcobalamin 750mcg

(as film coated tablet)

Colour: Iron Oxide Red

Approved colours used in capsule shell.

1049 Biotin Plus Minerals Tablets Each film coated tablet contains:

Biotin BP 10mg

N-Acetylcysteine USP 50mg

Calcium Pantothenate IP 50mg

Sodium Selenate USP eq. to elemental Selenium 65mcg

Cupric Oxide

Eq. to elemental Copper 3mg

Zinc Oxide IP eq. to elemental Zinc 22.5mg

Colour: Titanium Dioxide IP

1048 Aceclofenac Injection 1ml Each ml contains:

Aceclofenac IP 150mg

Excipients q.s.

1047 Methylcobalamin Injection Each ml contains:

Methylcobalamin 500mcg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1046 Iron, Folic Acid & Zinc Capsules Each hard gelatin capsule contains:

Ferrous Glycine Sulphate eq. to elemental Iron 100mg

Zinc Sulphate I.P

eq. to elemental zinc 7.5mg

Folic Acid IP 1mg

Approved colours used in capsule shell.

Appropriate overages of vitamin added

For therapeutic use

1045 Calcitriol Injection Each ml contains:-

Calcitriol BP 1mcg

Water for Injection IP q.s

1044 Levocarnitine Injection USP Each 5ml ampoule contains:-

Levocarnitine USP 1.0g

Page 20 of 252

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

1043 Drotaverine Hydrochloride & Pack (A) 2ml amploue:

Ranitidine Hydrochloride Combi Each ml contains:

Pack Injection Drotaverine Hydrochloride 20mg

Absolute Alcohol IP 8% v/v

Pack (B) 2ml ampoule:

Each ml contains:

Ranitidine Hydrochloride IP

Eq. to Ranitidine 25mg

Water for Injection IP q.s

1042 Methylcobalamin,Alpha Lipoic Each hard gelatin capsule contains: DCG (I) +

Acid & Vitamin Capsules Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

(Alpha Lipoic Acid 100mg in capsule)

Folic Acid IP 1.5mg

Thiamine Mononitrate IP 10mg

Pyridoxine Hydrochloride IP 3mg

Excipients q.s.

(Containing Mecobalamin and folic acid as film coated tablets)

Colour: Titanium Dioxide IP &

Iron Oxide Red

Appropriate overages of vitamins added to compensate for loss on storage.

Approved colours used in capsule shell.

1041 Mulvitamins Syrup Each 5ml contains:

Vitamin A BP 2500IU

(As Palmitate)

Vitamin E Acetate BP 5IU

(As di-a Tocopheryl Acetate)

Chloecalciferol BP 200 IU

Thiamine Hydrochloride BP 1mg

Riboflavin Sodium Phosphate BP 1mg

Pyridoxine Hydrochloride BP 1mg

Niacinamide BP 15mg

Cyanocobalamin BP 1mcg

D-Panthenol BP 2.5mg

Zinc Sulphate Heptahydrate BP

Eq. to zinc 3mg

Manganese Chloride USP

Eq. to Manganese 0.8mg

Page 21 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Sodium Molybdate Dihydrate BP

Eq. to Molybdenum 8mcg

Sodium Selenite USP

Eq. to Selenium 10mcg

Lysine Hydrochloride BP 100mg

In a flavoured syrup base

Colour: Quinoline yellow

Appropriate overages of vitamins add.

1041 Mulvitamins Syrup Each 5ml contains:

Vitamin A BP 2500IU

(As Palmitate)

Vitamin E Acetate BP 5 IU

(As di-a Tocopheryl Acetate)

Cholecalciferol BP 200 IU

Thiamine Hydrochloride BP 1mg

Riboflavin Sodium Phosphate BP 1mg

Pyridoxine Hydrochloride BP 1mg

Niacinamide BP 15mg

Cyanocobalamin BP 1mcg

D-Panthenol BP 2.5mg

Zinc Sulphate Heptahydrate BP

Eq. to Zinc 3mg

Manganese Chloride USP

Eq. to Manganese 0.8mg

Sodium Molybdate Dihydrate BP

In a flavoured syrup base

Colour: Quinoline yellow

Appropriate overages of vitamins add.

1040 Gabapentin & Methylcobalamin Each film coated tablet contains: DCG (I) +

Tablets Gabapentin USP 300mg

Eq. to Molybdenum 8mcg

Sodium Selenite USP

Eq. to Selenium 10mcg

Lysine Hydrochloride BP 30mg

Methylcobalamin 500mcg

Excipients q.s.

Colour: Ponceau 4R & Titanium Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

1039 Gabapentin & Methylcobalamin Each film coated tablet contains: DCG (I) +

Tablets Gabapentin USP 300mg Page 22 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Methylcobalamin 500mcg

Excipients q.s.

Colour: Ponceau 4R & Titanium Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

1038 Gabapentin & Methylcobalamin Each film coated tablet contains: DCG (I) +

Tablets Gabapentin USP 300mg

Methylcobalamin 500mcg

Excipients q.s.

Colour: Ponceau 4R & Titanium Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

1037 Folic Acid, Pyridoxine HCl & Each film coated tablet contains: DCG (I) +

Mecobalamin Tablets Folic Acid IP 1.5mg

Pyridoxine Hydrochloride IP 3mg

Mecobalamin 1500mcg

Colour: Red Oxide of Iron & Titanium

Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

1036 L-Ornithine L-Aspartate Injection Each ml solution contains:

L-Ornithine L-Aspartate 500mg

Water for Injection BP q.s

1035 a-ß Arteether Injection Each 2ml contains: a-ß Arteether 150mg

Arachis Oil IP q.s

1034 a-ß Arteether Injection Each ml contains: a-ß Arteether 75mg

Arachis Oil IP q.s

1033 Lactic Acid Bacillus with Vitamins Each 5ml of reconstituted suspension for Oral Suspension contains:

Lactic Acid Bacillus 40x10 6 Spores

Niacinamide IP 15mg

Follic Acid IP 100mcg

Vitamin B6 IP 1.5mcg

Zinc Sulphate Monohydrate USP

Eq. to Zinc 5mg colour: Sunset yellow FCF

Appropriate overages of vitamins added to compensate for loss on storage.

Page 23 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

1032 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains:

Acid & Vitamin Capsules Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Folic Acid IP 1.5mg

Thiamine Mononitrate IP 10mg

Pyridoxine Hydrochloride IP 3mg

(Containing Mecobalamin and folic acid as film coated tablets)

Colour: Titanium Dioxide IP &

Iron Oxide Red

Appropriate overages of vitamins added to compensate for loss on storage.

1031 Mulvitamins Syrup Each 5ml contains:

Vitamin A BP 2500IU

(As Palmitate)

Vitamin E Acetate BP 5 IU

(As di-a Tocopheryl Acetate)

Cholecalciferol BP 200 IU

Thiamine Hydrochloride BP 1mg

Riboflavin Sodium Phosphate BP 1mg

Pyridoxine Hydrochloride BP 1mg

Niacinamide BP 15mg

Cyanocobalamin BP 1mcg

D-Panthenol BP 2.5mg

Zinc Sulphate Heptahydrate BP

Eq. to Zinc 3mg

Manganese Chloride USP

Eq. to Manganese 0.8mg

Sodium Molybdate Dihydrate BP

Eq. to Molybdenum 8mcg

Sodium Selenite USP

Eq. to Selenium 10mcg

Lysine Hydrochloride BP 30mg

In a flavoured syrup base

Colour: Quinoline yellow

Appropriate overages of vitamins add.

1030 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) +

Acid & Vitamin Capsules Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride IP 3mg

Folic Acid IP 1.5mg

Page 24 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

(Containing Mecobalamin and folic acid as film coated tablets)

Colour: Titanium Dioxide IP &

Iron Oxide Red

Approved colours used in capsule shell.

Overages are added to compensate loss on storage.

1029 Azithromycin Tablets IP Each film coated tablet contains:

Azithromycin IP 250mg

Colour: Yellow Oxide or Iron

Titanium Dioxide IP

1028 Azithromycin Tablets IP Each film coated tablet contains:

Azithromycin IP 500mg

Colour: Yellow Oxide or Iron

Titanium Dioxide IP

1027 Azithromycin Oral Suspension Each 5ml contains:

Azithromycin IP 100mg flavoured syrup base q.s.

colour: Tartrazine supra

1026 Azithromycin Oral Suspension Each 5ml contains:

Azithromycin IP 200mg flavoured syrup base q.s.

Colour: Quinoline yellow WS

1025 Tramadol Hydrochloride Inj. Each ml contains:

Tramadol hydrochloride BP 50mg

Water for Injection IP q.s

1024 Tramadol Hydrochloride Inj. Each ml contains:

Tramadol hydrochloride BP 100mg

Water for Injection IP q.s

1023 Ondansetron Injection USP Each ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

Water for Injection IP q.s

1022 Ondansetron Injection USP Each ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

Water for Injection IP q.s

1021 Serratiopeptidase & Diclofenac Each enteric film coated tablet contains: DCG (I) +

Potassium Tablets Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units) Page 25 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Diclofenac Potassium BP 50mg

Colours: Sunset yellow (Lake) & Erythrosine

1020 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) +

Acid, Vitamin B6 & Folic Acid Cap Mecobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine HCl IP 3mg

Folic Acid IP 1.5mg

Appropriate overages of vitamins added to compensate loss on storage.

Approved colours used in capsule shell.

1019 Methylcobalamin, Vitamin B6 & Each 2ml contains:

Nicotinamide Injection Methylcobalamin 1000mcg

Pyridoxine HCl IP 100mg

Nicotinamide IP 100mg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1018 Multivitamins & Minerals Drops Each ml contains:

Vitamin D3 IP 200IU

Pyridoxine Hydrochloride IP 0.6mg

Niacinamide IP 5mg

D-Panthenol IP 1.5mg

Cyanocobalamin IP 1mcg

Folic Acid IP 50mcg

Ferric Ammonium Citrate IP eq. to elemental Iron 2mg

Copper Gluconate USP eq. to elemental Copper 100mcg

Magnesium Sulphate IP eq. to elemental Magnesium 5mg

Zinc Gluconate USP eq. to elemental Zinc 1mg flavoured base q.s.

1017 Mecobalamin, Vitamin B1, Each 3ml contains:

Vitamin B6, D-Panthenol, Mecobalamin 1000mcg

Vitamin B2 Phosphate Injection Thiamine Hydrochloride IP 100mg

Pyridoxine Hydrochloride IP 100mg

D-Panthenol IP 50mg

Nicotinamide IP 100mg

Riboflavin Sod. Phosphate IP 5mg

Page 26 of 252

DCG (I) +

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Benzyl Alcohol IP 2% w/v

(as preservative)

Phenol IP 0.5% w/v

(as preservative)

Water for Injection IP q.s

1016 Aceclofenac Injection Each ml contains:

Aceclofenac IP 150mg

Excipients: q.s

1015 Gabapentin & Mecobalamin Tabs Each film coated tablet contains: DCG (I) +

Gabapentin USP 300mg

Mecobalamin 500mcg

Excipients: q.s

Colour: Ponceau 4R & Titanium Dioxide IP

Approriate overages of vitamin added to compensate for loss on storage

1014 Methylcobalamin, Vitamin B6 & Each 2ml contains:

Nicotinamide Injection Methylcobalamin 1000mcg

Pyridoxine hydrochloride IP 100mg

Nicotinamide IP 100mg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1013 Mecobalamin Tablets Each film coated tablet contains:

Mecobalamin 500mcg colour: Erythrosine & Titanium Dioxide IP

1012 Diclofenac Potassium & Each enteric coated tablet contains: DCG (I) +

Serratiopeptidase Tablets Serratiopeptidase 10mg eq. to 20,000 units of Serratiopeptidase

Diclofenac Potassium BP 50mg

Colour: Sunset Yellow & Erythrosine

1011 Methylcobalamin Injection Each ml contains:

Methylcobalamin 500mcg

Benzyl Alcohol IP 2% w/v

(as preservative)

Water for Injection IP q.s

1010 Drotaverine Hydrochloride Inj. Each 2ml contains:

Drotaverine Hydrochloride 40mg

Absolute Alcohol IP 8% v/v

1009 Tramadol Hydrochloride Injection Each ml contains:

Water for Injection IP q.s

Tramadol Hydrochloride BP 50mg Page 27 of 252

DCG (I) +

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Water for Injections IP q.s

1008 Ondansetron Injection USP Each ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

Water for Injection IP q.s

1007 Levocarnitine Inj. USP Each 5ml contains:

Levocarnitine USP 1gm

Excipients: q.s

Water for Injection IP q.s

1006 Ondansetron Inj. USP Each ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

Water for Injection IP q.s

1005 Ondansetron Inj. USP Each ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

Water for Injection IP q.s

1004 L-Ornithine L-Aspartate Infusion Each 10ml contains:

L-Ornithine L-Aspartate 5gm

Water for Injection BP q.s

1003 Mecobalamin Tablets Each film coated tablet contains:

Mecobalamin 500mcg

Colour: Erythrosine & Titanium Dioxide IP

1002 Tetracycline Capsules BP 250mg Each capsule contains:-

Tetracycline Hydrochloride BP 250mg

Approved colours used in capsule shell.

1001 Doxycycline Capsules BP 100mg Each capsule contains:-

Doxycycline Hyclate BP

Eq. to Doxycycline 100mg

Approved colours used in capsule shell.

1000 Ranitidine Injection BP Each 2ml contains:

Ranitidine Hydrochloride BP

Eq. to Ranitidine 50mg

Water for Injection BP q.s

999 Mecobalamin Tablets Each film coated tablet contains:

Mecobalamin 500mcg

Colour: Erythrosine & Titanium Dioxide IP

998 Iron with Vitamins Capsules Each hard gelatin capsule contains:

Carbonyl Iron eq. to elemental Iron 100mg

Folic Acid BP 1.5mg

Page 28 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Vitamin B12 BP 15mcg

Vitamin C BP 75mg

Zinc Sulphate Monohydrate USP 61.8mg

Approved colours used in capsule shell.

997 Iron with Vitamins Capsules Each hard gelatin capsule contains:

Carbonyl Iron eq. to elemental Iron 50mg

Folic Acid BP 0.5mg

Zinc Sulphate Monohydrate USP 61.8mg

Approved colours used in capsule shell.

996 Methylcobalamin Injection Each ml contains:

Methylcobalamin 500mcg

Benzyl Alcohol BP 2% w/v

(as preservative)

Water for Injection BP q.s

995 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 500mg

Water for Injection BP q.s

994 Calcium Phosphate, Magnesium Each 10ml contains:

Hydroxide, Zinc Gluconate & Calcium Phosphate IP

Vitamin D3 Suspension eq. to elemental Calcium 300mg eq. to elemental Phosphorous 150mg

Magnesium Hydroxide IP eq. to elemental Magnesium 75mg

Zinc Gluconate USP eq. to elemental zinc 4mg

Vitamin D3 IP 200IU flavoured base q.s.

993 Aceclofenac, Paracetamol & Each film coated tablet contains:

Serratiopeptidase Tablets Aceclofenac IP 100mg

Paracetamol IP 500mg

Serratiopeptidase 15mg

(as enteric coated granules)

Excipients: q.s

Colour: Lake of Sunset Yellow FCF

992 Aceclofenac, Paracetamol & Each film coated tablet contains:

Serratiopeptidase Tablets Aceclofenac IP 100mg

Paracetamol IP 500mg

Serratiopeptidase 15mg

(as enteric coated granules)

Excipients: q.s

Page 29 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Lake of Sunset Yellow FCF

991 Acetylcysteine Injection BP Each ml contains:

Acetylcysteine BP 200mg

Water for Injection IP q.s.

990 Acetylcysteine Injection BP Each ml contains:

Acetylcysteine BP 200mg

Water for Injection IP q.s

989 Noradrenaline Bitartrate Inj. IP Each ml contains:

Noradrenaline Bitartrate IP 2mg

(Equivalent of Noradrenaline 1mg)

Water for Injection IP q.s.

988 Nitroglycerin Injection USP Each ml contains:

Nitroglycerin Solution IP

Equivalent to Nitroglycerine 5mg

Ethanol IP 30% v/v

Propylene Glycol IP 30% v/v

Water for Injection IP q.s.

987 Labetalol Injection B.P Each ml contains:

Labetalol Hydrochloride BP 5mg

Water for Injection IP q.s.

986 Calcium Phosphate, Magnesium Each 10ml contains:

Hydroxide, Zinc Gluconate & Calcium Phosphate IP

Vitamin D3 Suspension eq. to elemental Calcium 300mg eq. to elemental Phosphorous 150mg

Magnesium Hydroxide IP eq. to elemental Magnesium 75mg

Zinc Gluconate USP eq. to elemental zinc 4mg

Vitamin D3 IP 200IU flavoured base q.s.

985 Aceclofenac, Paracetamol & Each film coated tablet contains:

Serratiopeptidase Tablets Aceclofenac IP 100mg

Paracetamol IP 500mg

Serratiopeptidase 15mg

(as enteric coated granules)

Excipients: q.s

Colour: Lake of Sunset Yellow FCF

984 Acetylcysteine Injection BP Each ml contains:

Acetylcysteine BP 200mg

Water for Injection IP q.s.

983 Acetylcysteine Injection BP Each ml contains: Page 30 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Acetylcysteine BP 200mg

Water for Injection IP q.s

982 Noradrenaline Bitartrate Inj. IP Each ml contains:

Noradrenaline Bitartrate IP 2mg

(Equivalent of Noradrenaline 1mg)

Water for Injection IP q.s.

981 Nitroglycerin Injection USP Each ml contains:

Nitroglycerin Solution IP

Equivalent to Nitroglycerine 5mg

Ethanol IP 30% v/v

Propylene Glycol IP 30% v/v

Water for Injection IP q.s.

980 Labetalol Injection B.P Each ml contains:

Labetalol Hydrochloride BP 5mg

Water for Injection IP q.s.

979 Lornoxicam Tablets 4mg Each film coated tablet contains: DCG (I) +

Lornoxicam 4mg colour: Quinoline yellow lake &

Titanium Dioxide IP

978 Lornoxicam Tablets 8mg Each film coated tablet contains:

Lornoxicam 8mg colour: Quinoline yellow lake &

Titanium Dioxide IP

977 R-Ondansetron Hydrochloride Each dispersible tablet contains:

Dihydrate Dispersible Tablets R-Ondansetron Hydrochloride Dihydrate

Eq. to R-Ondansetron 4mg

976 R-Ondansetron Hydrochloride Each 5ml contains:

Dihydrate Oral Solution R-Ondansetron Hydrochloride Dihydrate eq. to Ondansetron 1mg

975 Muscrase Suspension Each 10ml contains:-

Sucralfate USP 1g flavoured q.s.

974 Diphenhydramine, ammonium Each 5ml contains: chloiride, sodium Citrate & Diphenhydramine HCl IP 14.08mg

Menthol Syrup Ammonium Chloride IP 138mg

Sodium Citrate IP 57.03mg

Menthol IP 1.14mg

flavour base q.s.

973 Loratadine Syrup Each 5ml contains:

Loratadine USP 5mg

Flavoured syrup base Page 31 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

972 Cetirizine, Dextromethorphan, Each 5ml contains:

Phenylepherine, Paracetamol, Cetirizine Dihydrochloride BP 2.5mg

Zinc & Menthol Syrup Dextromethophan HBr IP 7.5mg

Phenylephrine Hydrochloride BP 2.5mg

Paracetamol IP 250mg

Zinc Elemental

(as Zinc Gluconate USP) 7.5mg

Menthol IP 2.5mg

Flavoured syrup base q.s

971 Ambroxol, Terbutaline, Each 5ml contains:

Guaiphenesin & Menthol Syrup Ambroxol Hydrochloride BP 15mg

Terbutaline Sulphate IP 1.5mg

Guaiphenesin IP 50mg

Menthol IP 1.0mg

Colour: Tartazine Supra & Brilliant blue (S)

970 Ibuprofen Tablets B.P Each film coated tablet contains:

Ibuprofen BP 200mg

969 Ibuprofen Tablets B.P Each film coated tablet contains:

Ibuprofen BP 400mg

968 Ibuprofen Tablets B.P Each film coated tablet contains:

Ibuprofen BP 600mg

967 Tramadol Controlled Release Tabs Each film coated tablet contains:

Tramadol Hydrochloride 100mg

(In a controlled release system)

966 Ranitidine Hydrochloride Tabs 150mg Each film coated tablet contains:

Ranitidine Hydrochloride USP eq. to Ranitidine 150mg

965 Ranitidine Hydrochloride Tabs 300mg Each film coated tablet contains:

Ranitidine Hydrochloride USP eq. to Ranitidine 300mg

964 Ciprofloxacin Tabs USP 250mg Each film coated tablet contains:

Ciprofloxacin Hydrochloride USP

Eq. to Ciprofloxacin 250mg

963 Ciprofloxacin Tabs USP 500mg Each film coated tablet contains:

Ciprofloxacin Hydrochloride USP

Eq. to Ciprofloxacin 500mg

962 Calcium Carbonate Tabs USP Each uncoated tablet contains:

Calcium Carbonate USP 1.5gm

961 Tinidazole Tablets I.P Each film coated tablet contains:

Tinidazole I.P 500mg

960 Lansoprazole Caps 30mg Each hard gelatin capsule contains: Page 32 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Lansoprazole USP 30mg

(as enteric coated granules)

Approved colour used in capsule shells

959 Fluconazole Capsules 150mg Each hard gelatin capsule contains:

Fluconazole USP 150mg

Approved colour used in capsule shells

958 Tramadol Capsules BP Each hard gelatin capsule contains:

Tramadol Hydrochloride BP 50mg

Approved colour used in capsule shells

957 Tramadol Capsules BP Each hard gelatin capsule contains:

Tramadol Hydrochloride BP 100mg

Approved colour used in capsule shells

956 Omeprazole Capsules Each hard gelatin capsule contains:

Omeprazole BP 20mg

(as enteric coated granules)

Approved colour used in capsule shells

955 Piroxicam Capsules BP Each hard gelatin capsule contains:

Piroxicam BP 10mg

Approved colour used in capsule shells

954 Piroxicam Capsules BP Each hard gelatin capsule contains:

Piroxicam BP 20mg

Approved colour used in capsule shells

953 Orlistat Capsules 120mg Each hard gelatin capsule contains: DCG (I) +

Orlistat 120mg

Approved colour used in capsule shells

952 Pregabalin Capsules 150mg Each hard gelatin capsule contains: DCG (I) +

Pregabalin 150mg

Excipients q.s.

Approved colour used in capsule shells

951 Pregabalin Capsules 300mg Each hard gelatin capsule contains: DCG (I) +

Pregabalin 300mg

Excipients q.s.

Approved colour used in capsule shells

950 Omeprazole & Domperidone Tabs Each enteric coated tablet contains:-

Omeprazole Magnesium

Eq. to Omeprazole 10mg

Domperidone BP 15mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide IP

949 Sparfloxacin Tablets 200mg Each film coated tablet contains:

Sparfloxacin 200mg Page 33 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

948 Ofloxacin Tablets Each film coated tablet contains:

Ofloxacin USP 200mg

947 Loratadine Tablets Each uncoated tablet contains:

Loratadine USP 10mg

946 Etamsylate Tablets Each uncoated tablet contains:

Etamsylate BP 250mg

945 Etamsylate Tablets Each uncoated tablet contains:

Etamsylate BP 500mg

944 Diclofenac Sodium & Para Tablets Each uncoated tablet contains:

Diclofenac Sodium IP 50mg

Paracetamol IP 500mg

Colour: Sunset yellow FCF

943 Fluconazole Tablets 150mg Each uncoated tablet contains:

Flu conazole USP 150mg

942 Each uncoated tablet contains:

Cetirizine Dihydrochloride BP 2mg

Dextromethophan HBr IP 15mg

941 Tranexamic Acid Tablets B.P Each film coated tablet contains:

Tranexamic Acid B.P 500mg

940 Gliclazide Tablets Each uncoated tablet contains:

Gliclazide BP 80mg

939 Gliclazide & Metformin Tablets Each uncoated tablet contains:

Gliclazide BP 80mg

Metformin Hydrochloride IP 500mg

938 Frusemide Tablets IP 40mg Each uncoated tablet contains:

Frusemide IP 40mg

937 Ranititidine & Diclyclomine Tabs Each film coated tablet contains:

Ranitidine Hydrochloride USP eq. to Ranitidine 150mg

Dicyclomine Hydrochloride IP 10mg

936 Tranexamic Acid & Mefenamic Each film coated tablet contains: DCG (I) +

Acid Tablets Tranexamic Acid B.P 500mg

Mefenamic Acid IP 250mg

Colour: Yellow Oxide of Iron & Titanium

Dioxide IP

935 Fluconazole Tablets 50mg Each uncoated tablet contains:

Fluconazole USP 50mg

934 Diclofenac Tablets 50mg Each enteric -film coated tablet contains:

Diclofenac Sodium BP 50mg

933 Atenolol Tablets B.P Each uncoated tablet contains:

Atenolol BP 100mg Page 34 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

932 Enalapril Maleate Tablets USP Each uncoated tablet contains:

Enalapril Maleate USP 10mg

931 Famotidine Tablets B.P Each film coated tablet contains:

Famotidine BP 40mg

930 Ofloxacin & Ornidazole Tablets Each film coated tablet contains:

Ofloxacin IP 200mg

Ornidazole 500mg

Colour: Titanium Dioxide IP

929 Nimesulide & Paracetamol Tabs Each uncoated tablet contains:

Nimesulide BP 100mg

Paracetamol IP 500mg

Colour: Tartrazine Yellow

928 Labetalol Tablets B.P Each film coated tablet contains:

Labetalol Hydrochloride B.P 100mg

Colour: Quinoline Yellow

927 Ambroxol Hydrochloride, Terbutaline Each 5ml contains:

Sulphate, Guaiphenesin & Menthol Ambroxol Hydrochloride BP 15mg

Expectorant Terbutaline Sulphate IP 1.5mg

Guaiphenesin IP 50mg

Menthol IP 0.5mg

colour: Sunset yellow & Erythrosine

926 Camylofin Dihydrochloride Drop Each ml contains:

Camylofin Dihydrochloride 20mg flavoured syrupy base q.s.

Colour: Carmoisine

925 Levamisole Syrup Each 5ml contains:

Levamisole Hydrochloride IP eq. to Levamisole 50mg flavoured syrupy base q.s.

Colour: Carmoisine

924 Diclofenac Sodium Tabs B.P Each enteric coated tablet contains:-

Diclofenac Sodium BP 50mg

Colour: Sunset yellow

923 Albendazole Tablets Each uncoated chewable tablet contains:

Albendazole BP 400mg

Colour: Sunset yellow supra

922 Pantoprazole & domperidone Tabs Each enteric coated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 20mg

Domperidone BP 10mg

Colour: Titanium Dioxide IP & Page 35 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Yellow oxide of iron

921 Ondansetron Dispersible Tabs 4mg Each dispersible tablet contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

920 Pantoprazole & domperidone Tabs Each enteric coated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 20mg

Domperidone BP 10mg

Colour: Titanium Dioxide IP &

Yellow oxide of iron

919 Artesunate Tablets Each uncoated tablet contains:

Artesunate 50mg

918 Ondansetron Orally Disintegrating Each dispersible tablet contains:

Tablets USP Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

917 Ondansetron Oral Solution USP Each 5ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg flavour added

916 Orlistat Capsules 60mg Each hard gelatin capsule contains: DCG (I) +

Orlistat 60mg

Approved colour used in capsule shells

915 Orlistat Capsules 60mg Each hard gelatin capsule contains: DCG (I) +

Orlistat 60mg

Approved colour used in capsule shells

914 Ramipril Capsules 1.25mg Each hard gelatin capsule contains:

Ramipril BP 1.25mg

Excipients q.s.

Approved colour used in capsule shells

913 Ramipril Capsules 2.5mg Each hard gelatin capsule contains:

Ramipril BP 2.5mg

Excipients q.s.

Approved colour used in capsule shells

912 Ramipril Capsules 5mg Each hard gelatin capsule contains:

Ramipril BP 5mg

Excipients q.s.

Approved colour used in capsule shells

911 Fluoxetine Capsules USP Each capsule contains:

Fluoxetine Hydrochloride USP eq. to fluoxetine 20mg

Excipients q.s.

Page 36 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Approved colour used in capsule shells

910 Omeprazole Capsules IP 20mg Each capsule contains:

Omeprazole IP 20mg

(as enteric coated granules)

Excipients q.s.

Approved colour used in capsule shells

909 Pantoprazole & domperidone Caps Each hard gelatin capsule contains:

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 20mg

(as enteric coated tablets)

Colour: Tartrazine Yellow

Domperidone BP 10mg

Excipients q.s.

908 Ambroxol Hydrochloride, Terbutaline Each 5ml contains:

Sulphate, Guaiphenesin & Menthol Ambroxol Hydrochloride BP 15mg

Syrup Terbutaline Sulphate IP 1.5mg

Guaiphenesin IP 50mg

Menthol IP 1mg

Colour: Tartrazine yellow supra & Brilliant blue supra

907 Pyrantel Pamoate Oral Susp. USP Each ml contains:

Pyrantel Pamoate USP eq. to Pyrantel 25mg

In a flavoured base

906 Dextromethorphan HBr & Each 5ml contains:

Triprolidione HCl, Pseudoe- Dextromethorphan HBr IP 10mg phedrine HCl & Menthol Syrup Triprolidine Hydrochloride IP 1.25mg

Pseudoephedrine HCl IP 30mg

Menthol IP 1.5mg

In flavoured syrup base

905 Promethazine & Paracetamol Syp. Each 5ml contains:

Promethazine Hydrochloride IP 5mg

Paracetamol IP 125mg flavoured syrup base

904 Norfloxacin & Metronidazole Susp. Each 5ml contains:

Norfloxacin IP 100mg

Metronidazole Benzoate IP eq. to Metronidazole 100mg

In flavoured syrup base

903 Pyrantel Pamoate suspensoion Each 5ml contains:

Pyrantel Pamoate USP Page 37 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Pyrantel 250mg

In flavoured syrup base

902 Camylofin Dihydrochloride & Each 5ml contains:

Paracetamol Syrup Camylofin Dihydrochloride 12.5mg

Paracetamol IP 125mg flavoured syrupy base q.s.

Colour: Carmoisine

901 Albendazole Suspension Each 5ml contains:

Albendazole IP 200mg

Colour: Carmoisine

900 Codeine Phosphate & Each 5ml contains: chlorpheniramine Maleate Syrup Codeine Phosphate IP 10mg

Chlorpheniramine Maleate IP 4mg flavoured syrupy base q.s.

Colour: Carmoisine

899 Dextromethorphan HBr & Each 5ml contains: chlorpheniramine Maleate Syrup Dextromethorphan HBr IP 10mg

Chlorpheniramine Maleate IP 4mg flavoured syrupy base q.s.

Colour: Carmoisine

898 Terbutaline, Bromhexine, Each 5ml contains:

Guaiphenesin & Menthol Syrup Terbutaline Sulphate IP 1.25mg

Bromhexine HCl IP 4mg

Guaiphenesin IP 50mg

Mentholated syrupy base q.s.

colour: Brilliant blue FCF & Tartrazine yellow

897 Ambroxol, Salbutamol, Each 5ml contains:

Guaiphenesin & Menthol Syrup Ambroxol Hydrochloride BP 30mg

Salbutamol Sulphate IP eq. to Salbutamol 1mg

Guaiphenesin IP 50mg

Menthol IP 0.5mg

flavoured syrupy base q.s.

colour: Sunset yellow & Erythrosine

896 Magaldrate, Simethicone, Each 5ml contains:

Oxetacaine Suspension Magaldrate IP eq. to anhydrous Magaldrate 480mg

Simethicone IP 20mg

Oxetacaine BP 10mg

Colour: Quinoline Yellow WS

895 Paracetamol, Phenylepherine, Each 5ml contains: Page 38 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

CPM, Ammonium Chloride, Paracetamol IP 125mg

Sodium Citrate & Menthol Syrup Phenylephrine Hydrochloride IP 2.5mg

Chlorpheniramine Maleate IP 1mg

Ammonium Chloride IP 120mg

Sodium Citrate IP 60mg

Menthol IP 1.0mg

flavoured syrupy base q.s.

Colour: Ponceau 4R

894 Paracetamol, Phenylepherine, Each 5ml contains:

CPM, Ammonium Chloride, Paracetamol IP 250mg

Sodium Citrate & Menthol Syrup Phenylephrine Hydrochloride IP 2.5mg

Chlorpheniramine Maleate IP 2mg

Ammonium Chloride IP 120mg

Sodium Citrate IP 60mg

Menthol IP 1mg flavoured syrupy base q.s.

Colour: Erythrosine

893 Paracetamol & Nimesulide Susp. Each 5ml contains:

Paracetamol IP 125mg

Nimesulide BP 50mg

Colour: Quinolline Yellow FCF

892 Ambroxol Hydrochloride, Terbutaline Each 5ml contains:

Sulphate, Guaiphenesin & Menthol Ambroxol Hydrochloride BP 15mg

Expectorant Terbutaline sulphate IP 1.5mg

Guaiphenesin IP 50mg

Menthol IP 1mg

Colour: Tartrazine & Brilliant blue supra

891 Cetirizine dihydrochloride, Phenyl- Each 5ml contains: propanolamine HCl & Para susp. Cetirizine Dihydrochloride BP 2.5mg

Phenylpropanolamine HCL BP 10mg

Paracetamol IP 125mg

In flavoured syrup base

Colour: Ponceau 4R Supra

890 Ofloxacin & Ornidazole Suspension Each 5ml contains:

Ofloxacin USP 50mg

Ornidazole 125mg

Colour: Quinoline yellow FCF

889 Cetirizine dihydrochloride, Phenyl- Each 5ml contains: propanolamine HCl & Para susp. Cetirizine Dihydrochloride BP 2.5mg

Phenylpropanolamine Hydrochloride BP 10mg

Paracetamol IP 125mg Page 39 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

In flavoured syrup base

Colour: Ponceau 4R Supra

888 Ondansetron Hydrochloride Tablets Each film coated tablet contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

Colour: Titanium Dioxide IP

887 Ondansetron Hydrochloride Tablets Each film coated tablet contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 8mg

Colour: Sunset yellow FCF & Titanium Dioxide

886 Pantoprazole Sodium Tablets Each enteric coated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 20mg colour: Black oxide of Iron & Titanium Dioxide

885 Pantoprazole Sodium Tablets Each enteric coated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 40mg colour: Yellow oxide of Iron & Titanium Dioxide

884 S(-) Pantoprazole Sodium Tablets Each enteric coated tablet contains:-

S(-)Pantoprazole Sodium eq. to S(-) pantoprazole 20mg colour: Red oxide of Iron & Yellow oxide of Iron,

Titanium Dioxide IP

883 Levocetirizine dihydrochloride Tabs Each film coated tablet contains:

Levocetirizine Dihydrochloride 5mg

Colour: Titanium Dioxide IP

882 Rabeprazole Sodium Tablets Each enteric coated tablet contains:-

Rabeprazole Sodium 10mg colour: Yellow oxide of Iron & Titanium Dioxide

881 Rabeprazole Sodium Tablets Each enteric coated tablet contains:-

Rabeprazole Sodium 20mg colour: Yellow oxide of Iron & Titanium Dioxide

880 L-Ornithine L-Aspartate Tabs 150mg Each film coated tablet contains:

L-ornithine L-Asparatate 150mg

Colour:Iron oxide of Red & Titanium Dixoide IP

879 L-Ornithine L-Aspartate Tabs 500mg Each film coated tablet contains:

L-ornithine L-Asparatate 500mg

Colour:Iron oxide of Red & Titanium Dixoide IP

878 S(-) Amlodipine Besilate & Atenolol Each uncoated tablet contains:

Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Page 40 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Atenolol IP 25mg

Colour: Lake of Sunset yellow

877 S(-) Amlodipine Besilate & Atenolol Each uncoated tablet contains:

Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 5mg

Atenolol IP 50mg

Colour: Lake of Sunset yellow

876 S(-) Amlodipine Besilate & Losartan Each uncoated tablet contains:

Potassium Tablets S (-) Amlodipine Besilate eq. to Amlodipine 2.5mg

Losartan Potassium 50mg

Colour: Quinoline yellow WS

875 S(-) Amlodipine Besilate & Losartan Each uncoated tablet contains:

Potassium Tablets S (-) Amlodipine Besilate eq. to Amlodipine 2.5mg

Losartan Potassium 25mg

Colour: Lake of Quinoline yellow

874 Ramipril & (-) Amlodipine Tablets Each uncoated tablet contains:

Ramipril BP 2.5mg

S (-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Colour: Lake of sunset yellow

873 S(-) Pantoprazole Sodium Tablets Each enteri coated tablet contains:-

S(-) Pantoprazole sodium eq. to S (-) Pantoprazole 10mg colour: Red oxide of Iron & Yellow oxide of Iron,

Titanium Dioxide IP

872 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Colour: Yellow oxide of Iron, Red Oxide of Iron &

Titanium Dioxide IP

871 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 500mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

870 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 750mg

Colour:Yellow Oxide of Iron & Titanium Dixoide IP

869 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains: Page 41 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

S(-) Amlodipine Besilate eq. to Amlodipine 1.25mg

Colour: Yellow oxide of Iron

868 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to Amlodipine 2.5mg

Colour: Yellow oxide of Iron

867 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to Amlodipine 5mg

Colour: Yellow oxide of Iron

866 S (-) Amlodipine Besilate & Atenolol Each uncoated tablet contains:

Tablets S(-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Atenolol IP 50mg colour: Lake of sunset yellow

865 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac BP 100mg

Paracetamol IP 500mg

Colour: Lake of Quinoline yellow WS &

Titanium Dioxide IP

864 S(-) Amlodipine & Each uncoated tablet contains:

Hydrochlorthiazide Tablets S (-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Hydrochlorthiazide IP 12.5mg

colour: Lake of sunset yellow

863 Gatifloxacin Tablets 200mg Each film coated tablet contains:

Gatifloxiacin Sesquihydrate eq.. To Gatifloxacin 200mg colour: Lake of Quinoline yellow & Tio2

862 Gatifloxacin Tablets 400mg Each film coated tablet contains:

Gatifloxiacin Sesquihydrate eq.. To Gatifloxacin 400mg colour: Lake of Quinoline yellow & Tio2

861 Aceclofenac Tablets 100mg Each film coated tablet contains:

Aceclofenac BP 100mg

860 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac BP 100mg

Paracetamol IP 500mg

859 Sildenafil Citrate Tablets Each film coated tablet contains:

Sildenafil Citrate Page 42 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Sildenafil 50mg

Colour: Indigocarmine

858 Sildenafil Citrate Tablets Each film coated tablet contains:

Sildenafil Citrate eq. to Sildenafil 100mg

Colour: Indigocarmine

857 Omeprazole Magnesium Tabs Each enteri coated tablet contains:-

Omeprazole Magnesium eq. to Omeprazole 20mg

856 Levocetirizine dihydrochloride Tabs Each film coated tablet contains:

Levocetirizine Dihydrochloride 5mg

Colour: Titanium Dioxide IP

855 Levocetirizine dihydrochloride Tabs Each film coated tablet contains:

Levocetirizine Dihydrochloride 5mg

Colour: Titanium Dioxide IP

854 Naltrexone Hydrochloride Tablets Each uncoated tablet contains:

USP 50mg Naltrexone Hydrochloride USP 50mg

Excipients q.s.

colour: Yellow Oxide of Iron & Red oxide of Iron

853 Naltrexone Hydrochloride Tablets Each uncoated tablet contains:

USP 50mg Naltrexone Hydrochloride USP 50mg

Excipients q.s.

colour: Yellow Oxide of Iron & Red oxide of Iron

852 Losartan Potassium Tablets Each film coated tablet contains:

Losartan Potassium USP 50mg

Excipients q.s.

Colour: Titanium Dioxide IP

851 Albendazole Chewable Tablets Each uncoated tablet contains:

Albendazole IP 400mg colour: sunset yellow

850 Atorvastatin Tablets 10mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 10mg

848 Aceclofenac Tablets Each film coated tablet contains:

Aceclofenac BP 100mg

Excipients q.s.

colour: Titanium Dioxide IP

847 Paracetamol, Phenylepherine HCl, Each uncoated tablet contains: chlorpheniramine Maleate and Paracetamol IP 500mg

Caffeine Tablets Phenylephrine Hydrochloride IP 5mg

Chlorpheniramine Maleate IP 2mg Page 43 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

colour: Tartrazine

846 Aceclofenac & Paracetamol Tabs Each uncoated tablet contains:

Aceclofenac BP 100mg

Paracetamol IP 500mg

845 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac BP 100mg

Paracetamol IP 500mg

Colour: Lake of Quinoline yellow WS &

Titanium Dioxide IP

844 Ofloxacin Tablets Each film coated tablet contains:

Ofloxacin USP 200mg

Colour: Titanium Dioxide IP

843 Cetirizine dihydrochloride, Phenyl- Each uncoated tablet contains: propanolamine HCl & Para Tabs Cetirizine Dihydrochloride BP 5mg

Phenylpropanolamine Hydrochloride BP 10mg

Paracetamol IP 500mg

842 Rabeprazole Sodium Tablets 20mg Each entericoated tablet contains:-

Rabeprazole Sodium 20mg

841 Glucosamine & MSM Tablets Each film coated tablet contains:

Glucosamine Sulphate Potassium

Chloride USP 750mg

Methyl Sulphonyl Methane 250mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

840 Mirtazapine Mouth Dissolving Each uncoated tablet contains:

Tablets 7.5mg Mirtazapine USP 7.5mg

Excipients q.s.

839 Mirtazapine Tablets USP Each uncoated tablet contains:

Mirtazapine USP 30mg colour: Yellow oxide of Iron & Titanium Dioxide

838 Mirtazapine Mouth Dissolving Each uncoated tablet contains:

Tablets 15mg Mirtazapine USP 15mg

Excipients q.s.

Colour: Quinoline yellow

837 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac BP 100mg

Paracetamol IP 500mg colour: sunset yellow

836 Levocarnitine Tablets USP Each film coated tablet contains:

Levocarnitine USP 500mg

Excipients q.s.

Page 44 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Titanium Dioxide IP

835 L-Carnitine L-Tartrate Tablets Each film coated tablet contains:

L-Carnitine L-Tartrate 725mg eq. to L-Carnitine 500mg

Colour: Titanium Dioxide IP

834 Glimepiride Tablets Each uncoated tablet contains:

Glimepiride USP 2mg

Colour: Sunset yellow FCF

833 Ofloxacin Tablets Each film coated tablet contains:

Ofloxacin USP 200mg colour: Titanium Dioxide IP

832 Cetirizine HCl, Phenylpropanolamine Each uncoated tablet contains:

Hydrochloride & Paracetamol Tabs Cetirizine Dihydrochloride BP 5mg

Phenylpropanolamine Hydrochloride BP 10mg

Paracetamol IP 500mg

831 Rabeprazole Sodium Tablets 20mg Each entericoated tablet contains:-

Rabeprazole Sodium 20mg colour: Yellow oxide of Iron & Titanium Dioxide

830 S(-) Amlodipine & Each uncoated tablet contains:

Atorvastatin Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 5mg

Atorvastatin Calcium eq. to Atorvastatin 10mg

Colour: Lake of Quinoline yellow

829 S (-) Pantoprazole Sodium Tablets Each entericoated tablet contains:-

S (-) Pantoprazole Sodium eq. to S (-) Pantoprazole 10mg

Excipients q.s.

Colour: Red oxide of Iron, Yellow Oxide of Iron &

Titanium Dioxide IP

828 S (-) Pantoprazole Sodium Tablets Each entericoated tablet contains:-

S (-) Pantoprazole Sodium eq. to S (-) Pantoprazole 20mg

Excipients q.s.

Colour: Red oxide of Iron, Yellow Oxide of Iron &

Titanium Dioxide IP

827 S (-) Amlodipine Besilate & Each uncoated tablet contains:

Hydrochlorothiazide Tablets S (-) Amlodipine Besilate eq. to S (-) Amlodipine 5mg

Hydrochlorthiazide IP 12.5mg

Colour: Lake of Quinoline yellow Page 45 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

826 Etamsylate Tablets 250mg Each uncoated tablet contains:

Etamsylate BP 250mg

Colour: Iron oxide Red

825 Etamsylate Tablets 500mg Each uncoated tablet contains:

Etamsylate BP 500mg

Colour: Iron oxide Red

824 Losartan Potassium Tablets 50mg Each film coated tablet contains:

Losartan Potassium USP 50mg

Colour: Brilliant blue , Indigocarmine, and

Titanium Dioxide IP

823 Losartan Potassium Tablets 25mg Each film coated tablet contains:

Losartan Potassium USP 25mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

822 Losartan Potassium & Hydrochloro- Each film coated tablet contains: thiazide Tablets Losartan Potassium USP 50mg

Hydrochlorthiazide IP 12.5mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

821 Losartan Potassium & Atenolol Tabs Each film coated tablet contains:

Losartan Potassium USP 50mg

Atenolol IP 50mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

820 S(-) Amlodipine & Atorvastatin Tabs Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Atorvastatin Calcium eq. to Atorvastatin 10mg colour: Yellow Oxide of Iron

819 S(-) Amlodipine Besilate & Atenolol Each uncoated tablet contains:

Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Atenolol IP 25mg

Colour: Lake of Sunset yellow

818 S(-) Amlodipine Besilate & Atenolol Each uncoated tablet contains:

Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 5mg

Atenolol IP 50mg

Colour: Lake of Sunset yellow

817 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to S(-) amlodipine 1.25mg

Colour: Yellow oxide of Iron Page 46 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

816 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Colour: Yellow oxide of Iron

815 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to S(-) amlodipine 5mg

Colour: Yellow oxide of Iron

814 S(-) Amlodipine Besilate & Losartan Each uncoated tablet contains:

Potassium Tablets S (-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Losartan Potassium B.P 50mg

Colour: Lake of quinoline yellow

813 S (-) Amlodipine Besilate & Losartan Each uncoated tablet contains:

Potassium Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Losartan Potassium BP 25mg

Colour: Lake of Quinoline yellow

812 S (-) Amlodipine Besilate & Each uncoated tablet contains:

Hydrochloriothiazide Tablets S (-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Hydrochlorthiazide IP 12.5mg

Colour: Lake of Sunset yellow

811 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Colour: Yellow oxide of Iron, Red Oxide of Iron &

Titanium Dioxide IP

810 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 500mg

Colour: Titanium Dioxide IP

809 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 750mg

Colour: Titanium Dioxide IP

808 Indapamide Sustained Release Each film coated tablet contains:

Tablets 1.5mg Indapamide USP 1.5mg

Colour: Titanium Dioxide IP

807 Atorvastatin Tablets 5mg Each film coated tablet contains:

Atorvastatin Calcium Page 47 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Atorvastatin 5mg colour: Black oxide of Iron & Titanium Dioxide IP

806 Atorvastatin Tablets 10mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 10mg

Colour:Black oxide of Iron & Titanium Dioxide IP

805 Atorvastatin Tablets 20mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 20mg

Colour: Red oxide of iron , Yellow oxide of Iron &

Titanium Dioxide IP

804 Clopidogrel Tablets USP Each film coated tablet contains:

Clopidogrel Bisulfate USP eq. to Clopidogrel 75mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

803 S(-) Amlodipine Besilate & Atenolol Each uncoated tablet contains:

Tablets S(-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Atenolol IP 50mg colour: Lake of Sunset Yellow

802 Atorvastatin Tablets 40mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastain 40mg colour: Titanium Dioxide IP

801 Levocetirizine Tablets Each film coated tablet contains:

Levocetirizine Dihydrochloride 5mg

Colour: Titanium Dioxide IP

800 Pioglitazone hydrochloride tablets Each uncoated tablet contains:

Pioglitazone Hydrochloride eq. to Pioglitazone 15mg colour: Lake of Tartrazine

799 Pioglitazone hydrochloride tablets Each uncoated tablet contains:

Pioglitazone Hydrochloride eq. to Pioglitazone 30mg colour: Lake of Sunset yellow

798 Levocetirizine Tablets 5mg Each film coated tablet contains:

Levocetirizine Dihydrochloride 5mg

Colour: Titanium Dioxide IP

797 Atorvastatin Tablets 5mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 5mg Page 48 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS colour: Black oxide of Iron & Titanium Dioxide IP

796 Atorvastatin Tablets 10mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 10mg colour: Black oxide of Iron & Titanium Dioxide IP

795 Atorvastatin Tablets 20mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 20mg

Colour: Black oxide of Iron, Yellow Oxide of Iron

& Titanium Dioxide IP

794 Atorvastatin Tablets 40mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 40mg

Colour: Titanium Dioxide IP

793 Nimesulide & Paracetamol Tabs Each uncoated tablet contains:

Nimesulide BP 100mg

Paracetamol IP 325mg

Excipients q.s.

colour: Tartrazine

792 Glimepiride Tablets Each uncoated tablet contains:

Glimepiride USP 1mg

791 Glimepiride Tablets Each uncoated tablet contains:

Glimepiride USP 2mg

790 Aceclofenac Tablets Each film coated tablet contains:

Aceclofenac BP 100mg

Colour: Iron oxide yellow & titanium Dioxide IP

789 Losartan Potassium Tablets Each film coated tablet contains:

Losartan Potassium USP 25mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

788 Losartan Potassium Tablets Each film coated tablet contains:

Losartan Potassium USP 50mg

Colour:Titanium Dixoide IP

787 Losartan Potassium & Hydrochloro- Each film coated tablet contains: thiazide Tablets Losartan Potassium USP 50mg

Hydrochlorthiazide IP 12.5mg

colour: Lake of Quinoline yellow & Tio2

786 Amlodipine Besilate Tablets Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 2.5mg

785 Amlodipine Besilate Tablets Each uncoated tablet contains:

Amlodipine Besilate BP Page 49 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Amlodipine 5mg

Colour: Red oxide of Iron

784 Amlodipine Besilate Tablets Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 10mg

Colour: Ponceau 4R supra

783 Etamsylate Tablets Each uncoated tablet contains:

Etamsylate BP 250mg

782 Omeprazole Magnesium Tabs Each entericoated tablet contains:-

Omeprazole Magnesium eq. to Omeprazole 20mg colour: Iron oxide Red & Titanium Dioxide IP

781 Tranexamic Acid Tablets Each film coated tablet contains:

Tranexamic Acid B.P 500mg

Colour: Titanium Dioxide IP

780 Loratadine Tablets Each uncoated tablet contains:

Loratadine 10mg

779 Amlodipine & Atenolol Tablets Each uncoated tablet contains: NA

Amlodipine Besilate BP eq. to Amlodipine 5mg

Atenolol IP 50mg

778 Metformin Hydrochloride Tablets Each uncoated tablet contains: NA

IP 500mg Metformin Hydrochloride IP 500mg

777 Losartan Potassium Tablets IP Each film coated tablet contains: NA

Losartan Potassium IP 50mg

Colour: Titanium Dioxide

776 Losartan Potassium & Each film coated tablet contains: NA

Hydrochlorothiazide Tablets Losartan Potassium IP 25mg

Hydrochlorthiazide IP 12.5mg

Colour: Red Oxide of Iron & Titanium Dixoide IP

775 Zinc Acetate Dispersible Tabs 20mg Each uncoated dispersible tablet contains: NA

Zinc Acetate USP (as dehydrate) eq. to Elemental Zinc 20mg

Colour: Yellow oxide of Iron

774 Zinc Acetate Dispersible Tabs 50mg Each uncoated dispersible tablet contains: NA

Zinc Acetate USP (as dehydrate) eq. to Elemental Zinc 50mg

Colour: Titanium Dioxide IP

773 Aceclofenac & Paracetamol Tabs Each film coated tablet contains: NA

Aceclofenac IP 100mg

Paracetamol IP 500mg Page 50 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Titanium Dioxide IP

772 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac IP 100mg

Paracetamol IP 500mg

771 Alprazolam Tablets IP Each uncoated tablet contains:

Colour: Titanium Dioxide IP

770 Aprazolam Tablets IP Each uncoated tablet contains:

Alprazolam IP 0.25mg

Alprazolam IP 0.50mg

769 Fluconazole Tablets 200mg Each uncoated tablet contains:

Fluconazole 200mg

768 Fluconazole Tablets 150mg Each uncoated tablet contains:

Fluconazole 150mg

767 Fluconazole Tablets 50mg Each uncoated tablet contains:

Fluconazole 50mg

766 Tranexamic Acid Tablets 500mg Each film coated tablet contains:

Tranexamic Acid B.P 500mg

765 Tranexamic Acid Tablets 1000mg Each film coated tablet contains:

Tranexamic Acid B.P 1000mg

764 L-Ornithine L-Aspartate Tabs Each film coated tablet contains:

L-Carnitine L-Tartrate 725mg eq. to L-Carnitine 500mg

763 Alprazolam Tablets IP Each uncoated tablet contains:

Alprazolam IP 0.5, / 0.25 / 1mg

762 Astemizole Tablets IP Each uncoated tablet contains:

Astemizole IP 10mg

761 Diazepam Tablets IP Each uncoated tablet contains:

Diazepam IP 5mg

760 Salbutamol Sulphate Tabs IP 4mg Each uncoated tablet contains:

Salbutamol Sulphate IP eq. to Salbutamol 4mg

759 Tinidazole Tablets IP Each uncoated tablet contains:

Tinidazole IP 500mg

758 Trimethorprim & Each uncoated tablet contains:

Sulphamethoxazole Tabs Trimethoprim IP 80mg

Sulphamethoxazole IP 400mg

757 Dicyclomine Tablets Each uncoated tablet contains:

Dicyclomine Hydrochloride IP 10mg

756 Phenytoin Tablets Each film coated tablet contains:

Phenytoin Sodium BP 100mg

755 Frusemide Tablets 20mg Each uncoated tablet contains: Page 51 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Frusemide BP 20mg

754 Ciprofloxacin Hydrochloride Each film coated tablet contains:

Tablets IP 500mg Cipfloxacin Hydrochloride IP eq. to Ciprofloxacin 500mg

Colour: Ponceau 4R & Titaniumd Dioxide IP

753 Ciprofloxacin Hydrochloride Each film coated tablet contains:

Tablets IP 250mg Cipfloxacin Hydrochloride IP eq. to Ciprofloxacin 250mg

Colour: Ponceau 4R & Titaniumd Dioxide IP

752 Paracetamol Syrup I.P Each 5ml contains:

Paracetamol IP 125mg

751 Salbutamol Sulphate Syrup I.P Each 5ml contains:

Salbutamol Sulphate IP eq. to Salbutamol 2mg

750 Cotrimoxazole Oral Each 5ml contains: suspension IP Trimethoprim IP 40mg

Sulphamethoxazole IP 200mg

749 Metronidazole Benzoate Oral Susp. Each 5ml contains:

Metronidazole Benzoate IP eq. to Metronidazole 100mg

748 Dextromethorphan HCl & Each 5ml contains:

Promethazine Hydrochloride Dextromethorphan HCl IP 10mg

Syrup Promethazine Hydrochloride IP 5mg flavoured syrupy base q.s.

747 Liquid Parafin, Milk of Magnesia, Each 5ml contains:

Sodium Picosulphate syrup Liquid Parafin IP 1.25ml

Milk of Magnesia IP 3.75ml

Sodium Picosulphate BP 3.33mg

Colour: Erythrosine supra

746 Paracetamol, Dextromethorphan, Each 5ml contains:

CPM Cough syrup Paracetamol IP 125mg

Dextromethorphan HCl IP 5mg

Chlorpheniramine Maleate IP 1mg flavoured syrupy base q.s.

745 Potassium Magnesium, Each uncoated tablet contains:

Magnesium Iron Tablets Potassium Magnesium Citrate 978mg

(Each tablet contains approximately 3.5mEq.

Magnesium Ion, 7mEq. Potassium Ion and

10.5mEq. of Citrate Ion)

744 Albendazole Chewable Tablets Each uncoated chewable tablet contains:

Albendazole IP 400mg Page 52 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

743 Atenolol Tablets IP Each uncoated tablet contains:

Atenolol IP 50mg

742 Captopril Tablets IP Each uncoated tablet contains:

Captopril IP 25mg

741 Captopril Tablets IP Each uncoated tablet contains:

Captopril IP 50mg

740 Carbamazepine Tablets IP Each uncoated tablet contains:

Carbamazepine IP 200mg

739 Glibenclamide Tablets Each uncoated tablet contains:

Glibenclamide IP 2.5mg

738 Paracetamol Tablets Each uncoated tablet contains:

Paracetamol IP 500mg

737 Mebendazole Tablets IP Each uncoated tablet contains:

Mebendazole IP 100mg

736 Aciclovir Tablets BP Each uncoated tablet contains:

Aciclovir BP 200mg

735 Propranolol HCl Tablets IP Each uncoated tablet contains:

Propranolol Hydrochloride IP 40mg

734 Metoclopramide HCl Tabs Ip Each uncoated tablet contains:

Anhydrous Metoclopramide HCl IP 10mg

733 Metronidazole Tablets IP Each uncoated tablet contains:

Metronidazole IP 400mg

732 Nifedipine Tabs IP 20mg Each uncoated tablet contains:

Nifedipine IP 20mg

731 Amlodipine Tablets 10mg Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 10mg

730 Piroxicam Tablets 20mg Each uncoated tablet contains:

Piroxicam BP 20mg

729 Cetirizine Tablets 10mg Each film coated tablet contains:

Cetirizine Dihydrochloride BP 10mg

728 Bromhexine Tablets 8mg Each uncoated tablet contains:

Bromhexine HCl BP 8mg

727 Levocetirizine dihydrochloride Tabs Each film coated tablet contains:

Levocetirizine Dihydrochloride 5mg

Colour: Titanium Dioxide IP

726 Paracetamol & Domperidone Tabs Each film coated tablet contains:

Paracetamol IP 500mg

Domperidone BP 20mg

Colour: Titanium Dioxide IP

725 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains: Page 53 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

S(-) Amlodipine Besilate eq. to S (-) Amlodipine 1.25mg

Colour: Yellow oxide of Iron

724 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Colour: Yellow oxide of Iron

723 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S(-) Amlodipine Besilate eq. to S (-) Amlodipine 5mg

Colour: Yellow oxide of Iron

722 S(-) Amlodipine & Losartan Each uncoated tablet contains:

Potassium Tablets S(-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Losartan Potassium IP 50mg

Colour: Lake of Quinoline yellow

721 S(-) Amlodipine & Losartan Each uncoated tablet contains:

Potassium Tablets S(-) Amlodipine Besilate eq. to S (-) Amlodipine 5mg

Losartan Potassium IP 50mg

Colour: Lake of Quinoline yellow

720 Aceclofenac Tablets IP 100mg Each film coated tablet contains:

Aceclofenac IP 100mg

Colour: Titanium Dioxide IP

719 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac IP 100mg

Paracetamol IP 500mg

718 Gliclazide Tablets BP Each uncoated tablet contains:

Colour: Titanium Dioxide IP

Gliclazide BP 80mg

717 Ondansetron Mouth Dissolving Tabs Each uncoated mouth dissolving tablet contains

Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

716 Nimesulide & Paracetamol Susp. Each 5ml contains:

Nimesulide BP 50mg

Paracetamol IP 125mg flavoured syrupy base q.s.

Colour: Sunset Yellow

715 Nimesulide & Paracetamol Tabs Each uncoated dispersible tablet contains:

Nimesulide BP 50mg

Paracetamol IP 125mg Page 54 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

Colour: Tartrazine yellow

714 Metformin Hydrochloride Tablets IP Each uncoated tablet contains:

Metformin Hydrochloride IP 500mg

713 Metronidazole Oral Suspension Each 5ml contains:

Metronidazole Benzoate BP eq. to Metronidazole 100mg

712 Co-Trimoxazole Oral Susp. B.P Each 5ml contains:

Trimethoprim BP 40mg

Sulfamethoxazole BP 200mg

711 Salbutamol Oral Solution BP Each 5ml contains:

Salbutamol Sulphate BP eq. to Salbutamol 2mg

710 Albendazole Oral Suspension Each 5ml contains:

Albendazole BP 200mg

709 Mebendazole Oral Suspension Each 5ml contains:

Mebendazole BP 100mg

708 Albendazole Suspension Each 5ml contains:

Albendazole IP 200mg flavoured syrupy base q.s.

Colour: Sunset yellow

707 Ondansetron Oral Solution USP Each 5ml contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg flavoured syrupy base q.s.

Colour: Ponceau 4R

706 Clomifene Kit Each kit contains:

705 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide IP

704 Glimepiride Tablets Each uncoated tablet contains:

Glimepiride USP 1mg

703 Glimepiride Tablets Each uncoated tablet contains:

A. One Clomifene Tablets IP

Each uncoated tablet contains:

Clomifene Citrate IP 300mg

B. Two Copper Sulphate Tablets

Each uncoated tablet contains:

Copper Sulphate Pentahydrate BP 750mg

Page 55 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Glimepiride USP 2mg

702 Glimepiride Tablets Each uncoated tablet contains:

Glimepiride USP 4mg

701 Nitazoxanide Tablets Each film coated tablet contains:

Nitazoxanide 500mg colour: Lake of Quinolline yellow WS &

Titanium Dioxide IP

700 Levofloxacin Tablets 250mg Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide IP

699 Levofloxacin Tablets 500mg Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 500mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide IP

698 Levofloxacin Tablets 750mg Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 750mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide IP

697 Psyllium Hydrophilic Mucilloid for Each 07gm contains:

Oral Suspension USP Psyllium Husk USP 3.479gm

(Plantago ovata Forssk)

Sucrose BP 3.465gm

Dextrose USP 0.056gm

696 Ispaghula Husk Each 100gm contains:-

Ispaghula Husk IP 49.7gm

(Plantago ovata Forssk)

Excipients q.s.

695 Bethistine Dihydrochloride Each uncoated tablet contains:

Tablets B.P. 24mg Betahistine Dihydrochloride BP 24mg

Colour: Quinoline Yellow

694 Gliclazide Tablets BP 30mg Each uncoated tablet contains:

Gliclazide BP 30mg colour: Iron oxide Red

693 Gliclazide Tablets BP 40mg Each uncoated tablet contains:

Gliclazide BP 40mg colour: Iron oxide Red

692 Gliclazide Tablets BP 60mg Each uncoated tablet contains: Page 56 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Gliclazide BP 60mg

Colour: Indigocarmine

691 Pantoprazole Sodium Tablets 40mg Each entericoated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 40mg

Colour: Iron oxide yellow & titanium Dioxide IP

690 Pantoprazole Sodium Tablets 20mg Each entericoated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 20mg

Colour: Iron oxide yellow & titanium Dioxide IP

689 Carvedilol Tablets 12.5mg Each uncoated tablet contains:

Carvedilol BP 12.5mg

688 Carvedilol Tablets 25mg Each uncoated tablet contains:

Carvedilol BP 25mg

687 Atorvastatin Tablets 10mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastan 10mg

Colour: Black Oxide of Iron &

Titanium Dioxide BP

686 Atorvastatin Tablets 20mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastan 20mg

Colour: Red Oxide of Iron, Yellow oxide Iron &

Titanium Dioxide BP

685 Albendazole Suspension Each 5ml contains:

Albendazole BP 200mg

Colour: Sunset yellow FCF

684 Nimesulide suspension Each 5ml contains:

Nimesulide BP 50mg

Colour: Quinoline Yellow

683 Ibuprofen & Paracetamol Suspension Each 5ml contains:

Ibuprofen BP 100mg

Paracetamol BP 125mg

Colour: Sunset yellow

682 Nimesulide & Paracetamol Susp. Each 5ml contains:

Nimesulide BP 50mg

Paracetamol BP 125mg

Colour: Quinoline Yellow

681 Salbutamol, Guaiphenesine, Each 10ml contains:-

Bromhexine & Menthol Syrup Salbutamol Sulphate BP eq. to Salbutamol 2mg Page 57 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Guaiphenesin BP 100mg

Bromhexine HCl BP 4mg

Menthol USP 1mg flavoured syrupy base q.s.

680 Cetirizine, Dextromethorphan, Each 5ml contains:

Phenylphrine, Paracetamol, Cetirizine Dihydrochloride BP 2.5mg

Zinc & Menthol Syrup Dextromethorphan HBr BP 7.5mg

Phenylphrine Hydrochloride BP 2.5mg

Paracetamol BP 250mg

Zinc Elemental

(as Zinc Gluconate USP) 7.5mg

Menthol BP 2.5mg

flavoured syrupy base q.s.

Colour: Ponceau 4R

679 Diphenhydramine, Ammonium Each 5ml contains:

Sodium Citrate & Menthol Syrup Diphenhydramine Hydrochloride 14.08mg

Ammonium Chloride BP 138mg

Sodium Citrate BP 57.03mg

Menthol BP 1.14mg

flavoured syrupy base q.s.

colour: Erythrosine, Sunset yellow FCF &

Caramel

678 Omeprazole capsules 20mg Each hard gelatin capsule contains:

Omeprazole BP 20mg

(enteric coated granules)

677 Zidovudine Capsules 100mg Each hard gelatin capsule contains:

Zidovudine USP 100mg

675 Sibutramine hydrochloride Mono- Each hard gelatin capsule contains: hydrate Capsules Sibutramine Hydrochloride Monohydrate 10mg

Excipients q.s.

Approved colours used in capsule shell.

674 Celecoxib Capsules 200mg Each hard gelatin capsule contains:

Celecoxib 200mg

Approved colours used in capsule shell.

673 Celecoxib Capsules 100mg Each hard gelatin capsule contains:

Celecoxib 100mg

Approved colours used in capsule shell.

672 Calcium Dobesilate Caps 500mg Each hard gelatin capsule contains:

Calcium Dobesilate monohydrate BP eq. to Calcium Dobesilate anhydrous 500mg

Approved colours used in capsule shell.

Page 58 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

671 Orlistat Capsules 120mg Each hard gelatin capsule contains:

Orlistat 120mg

(as pellets 50% w/w)

Approved colours used in capsule shell.

670 Orlistat Capsules 60mg Each hard gelatin capsule contains:

Orlistat 60mg

(as pellets 50% w/w)

Approved colours used in capsule shell.

669 Fluoxetine Caps USP 20mg Each hard gelatin capsule contains:

Fluoxetine Hydrochloride USP eq. to fluoxetine 20mg

Excipients q.s.

Approved colours used in capsule shell.

668 Celecoxib Capsules 200mg Each hard gelatin capsule contains:

Celecoxib 200mg

Approved colours used in capsule shell.

667 Celecoxib Capsules 100mg Each hard gelatin capsule contains:

Celecoxib 100mg

Approved colours used in capsule shell.

666 Tramadol Capsules BP 50mg Each hard gelatin capsule contains:

Tramadol Hydrochloride BP 100mg

665 Clindamycin Capsules 300mg Each hard gelatin capsule contains:

Clindamycin Hydrochloride BP 300mg

664 Indomethacin Capsules BP Each hard gelatin capsule contains:

Indometacin BP 25mg

663 Effevarenz Capsules IP Each hard gelatin capsule contains:

Effevarenz IP 200mg

662 Zidovudine Capsules 300mg Each hard gelatin capsule contains:

Zidovudine USP 300mg

Approved colours used in capsule shell.

661 Ramipril Capsules BP 1.25mg Each hard gelatin capsule contains:

Ramipril BP 1.25mg

Approved colours used in capsule shell.

660 Ramipril Capsules BP 5mg Each hard gelatin capsule contains:

Ramipril BP 5mg

Approved colours used in capsule shell.

659 Ramipril Capsules BP 2.5mg Each hard gelatin capsule contains:

Ramipril BP 2.5mg

Approved colours used in capsule shell.

658 Valsartan Capsules 40mg Each hard gelatin capsule contains:

Valsartan 40mg Page 59 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Approved colours used in capsule shell.

657 Valsartan Capsules 60mg Each hard gelatin capsule contains:

Valsartan 60mg

Approved colours used in capsule shell.

656 Omeprazole Capsles 10mg Each hard gelatin capsule contains:

Omeprazole BP 10mg

(as enteric coated pellets)

Approved colours used in capsule shell.

655 Omeprazole Capsles 20mg Each hard gelatin capsule contains:

Omeprazole BP 20mg

(as enteric coated pellets)

Approved colours used in capsule shell.

654 Gemfibrozil Tablets BP Each film coated tablet contains:

Gemfibrozil BP 600mg

653 Salbutamol Tablets BP Each uncoated tablet contains:

Salbutamol Sulphate BP eq. to Salbutamol 4mg

652 Cinnarizine Tablets 25mg Each uncoated tablet contains: NA

Cinnarizine BP 25mg

651 Theophylline Tablets USP 125mg Each uncoated tablet contains:

Theophylline (anhydrous) USP 125mg

650 Acetazolamide Tablets BP Each uncoated tablet contains:

Acetazolamide BP 250mg

649 Aspirin Tablets BP Each uncoated tablet contains:

Aspirin BP 300mg

648 Calcium Carbonate Tablets USP Each uncoated tablet contains:

Calcium Carbonate USP 600mg

647 Griseofulvin Tablets BP Each uncoated tablet contains:

Griseofulvin BP 125mg

646 Ketoconazole Tablets USP Each uncoated tablet contains:

Ketoconazole USP 200mg

645 Metformin Tablets BP Each film coated tablet contains:

Metformin Hydrochloride BP 500mg

644 Mebendazole Tablets USP Each uncoated tablet contains:

Mebendazole USP 100mg

643 Mefenamic Acid Tablets BP Each uncoated tablet contains:

Mefenamic Acid BP 500mg

642 Co-Trimoxazole Tablets BP Each uncoated tablet contains:

Trimethoprim BP 80mg

Sulfamethoxazole BP 400mg

641 Phenytoin Tablets BP Each film coated tablet contains: Page 60 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Phenytoin Sodium BP 100mg

640 Pseudoephedrine Tablets BP Each uncoated tablet contains:

Pseudoephedrine BP 60mg

639 Losartan Tablets 50mg Each film coated tablet contains:

Losartan Potassium 50mg

638 Spironolactone Tablets BP 100mg Each uncoated tablet contains:

Spironolactone BP 100mg

637 Tranexamic Acid Tablets BP 250mg Each film coated tablet contains:

Tranexamic Acid BP 250mg

Colour: Titanium Dioxide BP

636 Lisinopril Tablets USP 2.5mg Each uncoated tablet contains:

Lisinopril USP eq. to anhydrous Lisinopril 2.5mg

Colour: Yellow Oxide of Iron

635 Lisinopril Tablets USP 10mg Each uncoated tablet contains:

Lisinopril USP eq. to anhydrous Lisinopril 10mg

634 Ofloxacin Tablets 200mg Each film coated tablet contains:

Ofloxacin USP 200mg

Colour: Titanium Dioxide BP

633 Ofloxacin Tablets 400mg Each film coated tablet contains:

Ofloxacin USP 400mg

Colour: Titanium Dioxide BP

632 Tranexamic Acid Tablets BP 250mg Each film coated tablet contains:

Tranexamic Acid BP 250mg

Colour: Titanium Dioxide BP

631 Fluconazole Tablets 150mg Each uncoated tablet contains:

Fluconazole USP 150mg

Colour: Indigocarmine

630 Ibuprofen & Paracetamol Tablets Each film coated tablet contains:

Ibuprofen BP 400mg

Paracetamol BP 500mg

Colour: Ponceau 4R Lake&Titanium Dioxide BP

629 Captopril Tablets BP 12.5mg Each uncoated tablet contains:

Captopril BP 12.5mg

628 Glimepiride Tablets 1mg Each uncoated tablet contains:

Glimepiride USP 1mg

627 Glimepiride Tablets 2mg Each uncoated tablet contains:

Glimepiride USP 2mg

Colour: Sunset yellow

626 Glimepiride Tablets 3mg Each uncoated tablet contains: Page 61 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Glimepiride USP 3mg

Colour: Lake of quinoline yellow

625 Glimepiride Tablets 4mg Each uncoated tablet contains:

Glimepiride USP 4mg

Colour: Ponceau 4R supra

624 Betahistine dihydrochloride Each uncoated tablet contains:

Tablets B.P. 16mg Betahistine Dihydrochloride BP 16mg

Colour: Sunset yellow lake

623 Betahistine dihydrochloride Each uncoated tablet contains:

Tablets B.P. 8mg Betahistine Dihydrochloride BP 8mg

622 Clopidogrel Tablets USP 75mg Each film coated tablet contains:

Clopidogrel Bisulfate USP eq. to Clopidogrel 75mg

Colour: Red Oxide of Iron & Titanium Dixoide BP

621 Esomeprazole Tablets 20mg Each entericoated tablet contains:-

Esomeprazole Magnesium Trihydrate eq. to Esomeprazole 20mg

Colour: Red Oxide Iron & Titanium Dioxide BP

620 Esomeprazole Tablets 40mg Each entericoated tablet contains:-

Esomeprazole Magnesium Trihydrate eq. to Esomeprazole 40mg

Colour: Red Oxide Iron & Titanium Dioxide BP

619 Nabumetone Tablets BP 500mg Each film coated tablet contains:

Nabumetone BP 500mg

Colour: Red Oxide Iron & Titanium Dioxide BP

618 Tranexamic Acid Tablets BP 250mg Each film coated tablet contains:

Tranexamic Acid BP 250mg

Colour: Titanium Dioxide BP

617 Tranexamic Acid Tablets BP 500mg Each film coated tablet contains:

Tranexamic Acid BP 500mg

Colour: Titanium Dioxide BP

616 Rabeprazole Sodium Tablets 20mg Each entericoated tablet contains:-

Rabeprazole Sodium 20mg

Colour:Yellow Oxide Iron & Titanium Dioxide BP

615 Rabeprazole Sodium Tablets 10mg Each entericoated tablet contains:-

Rabeprazole Sodium 10mg

Colour:Yellow Oxide Iron & Titanium Dioxide BP

614 Glucosamine & MSM Tablets Each film coated tablet contains:

Glucosamine Sulphate Potassium

Chloride USP 750mg

MSM 250mg Page 62 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Red Oxide Iron & Titanium Dioxide BP

613 Gliclazide Tablets BP 80mg Each uncoated tablet contains:

Gliclazide BP 80mg

612 Topiramate Tablets 100mg Each film coated tablet contains:

Topiramate 100mg

Colour: Quinoline Yellow & Titanium Dioxide BP

611 Metformin Tablets BP 500mg Each film coated tablet contains:

Metformin Hydrochloride BP 500mg

Colour: Titanium Dioxide BP

610 Nifedipine Tablets 20mg Each film coated tablet contains:

Nifedipine BP 20mg

609 Oxcarbazepine Tablets 150mg Each film coated tablet contains:

Oxcarbazepine 150mg

Colour: Yellow Oxide of Iron

608 Oxcarbazepine Tablets 300mg Each film coated tablet contains:

Oxcarbazepine 300mg

Colour: Yellow Oxide of Iron

607 Oxcarbazepine Tablets 600mg Each film coated tablet contains:

Oxcarbazepine 600mg

Colour: Yellow Oxide of Iron

606 Diclofenac sodium & Paracetamol Each uncoated tablet contains:

Tablets Diclofenac Sodium BP 50mg

(as enteric coated granule)

Paracetamol BP 500mg

605 Nimesulide & Paracetamol Tabs Each uncoated tablet contains:

Nimesulide BP 100mg

Paracetamol BP 500mg

604 Cetirizine, Phenylephrine, Each uncoated tablet contains:

Paracetamol, Dextromethorphan Cetirizine Dihydrochloride BP 2mg

& Caffeine Tablets Phenylephrine Hydrochloride BP 5mg

Paracetamol BP 500mg

Dextromethorphan HBr BP 15mg

Caffeine BP 15mg

603 Ketorolac Tromethamine Tabs USP Each film coated tablet contains:

Ketorolac Tromethamine USP 10mg

Colour: Titanium Dioxide BP

602 Spironolactone Tablets BP 100mg Each uncoated tablet contains:

Spironolactone BP 25mg

601 Glyceryl Trinitrate Tabs BP 0.5mg Each uncoated sublingual tablet contains:

Glyceryl Trinitrate BP 0.5mg

600 Nifedipine ER Tablets USP 20mg Each extended release tablet contains: Page 63 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Nifedipine USP 20mg

599 Captopril Tablets BP 25mg Each uncoated tablet contains:

Captopril BP 25mg

598 Nimesulide Tabs 200mg Each uncoated tablet contains:

Nimesulide BP 200mg

597 Nimesulide Dispersible Tablets 50mg Each uncoated dispersible tablet contains:

Nimesulide BP 50mg

596 Topiramate Tablets 50mg Each film coated tablet contains:

Topiramate 50mg

Colour:Tartrazine yellow & Titanium Dioxide BP

595 Topiramate Tablets 25mg Each film coated tablet contains:

Topiramate 25mg

Colour:Sunset yellow & Titanium Dioxide BP

594 Acetazolamide Tablets BP 250mg Each uncoated tablet contains:

Acetazolamide BP 250mg

593 Acetazolamide Tablets BP 250mg Each uncoated tablet contains:

Acetazolamide BP 250mg

592 Atorvastatin Tablets 20mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastain 20mg

Colour: Red oxide Iron, Yellow Oxide Iron &

Titanium Dioxide BP

591 Losartan Potassium Tablets 50mg Each film coated tablet contains:

Losartan Potassium USP 50mg

Excipients q.s.

Colour: Titanium Dioxide q.s.

590 Naltrexone Hydrochloride Each uncoated tablet contains:

Tablets USP 50mg Naltrexone Hydrochloride USP 50mg

Colour: Yellow Oxide Iron & Red Oxide Iron

589 Acetazolamide Tablets BP 250mg Each uncoated tablet contains:

Acetazolamide BP 250mg

588 Lamivudine Tablets 150mg Each film coated tablet contains:

Lamivudine BP 150mg

Colour: Titanium Dioxide BP

587 Felodipine Extended Release Each film coated extended release

Tablets USP tablet contains:

Felodipine USP 5mg

Colour: Tartrazine & Titanium Dioxide BP

586 Felodipine Extended Release Each film coated extended release

Tablets USP tablet contains:

Felodipine USP 10mg Page 64 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Brilliant blue & Titanium Dioxide BP

585 Albendazole Tablets Each uncoated chewable tablet contains:

Albendazole BP 200mg

Colour: Sunset yellow supra

584 Risperidone Tablets Each film coated tablet contains:

Risperidone BP 2mg

Colour: Sunset yellow & Titanium Dioxide BP

583 Loratadine & Pseudoephedrine Each uncoated tablet contains:

Sulfate Tablets Loratadine USP 10mg

Pseudoephedrine Sulfate USP 180mg

(as extended release)

582 Albendazole Tablets 200mg Each uncoated chewable tablet contains:

Albendazole BP 200mg

581 Theophylline Tablets 300mg Each uncoated SR tablet contains:

Anhydrous Theophylline USP 300mg

580 Pantoprazole Sodium Tablets 40mg Each entericoated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 40mg

Excipients q.s.

Colour:Yellow oxide Iron & Titanium Dioxide BP

579 Sildenafil Citrate Tablets 100mg Each filmcoated tablet contains:-

Sildenafil Citrate eq. to Sildenafil 100mg

578 Amlodipine Besylate Tablets Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 5mg

577 Trimethoprim, Sulfamethoxazole Each uncoated tablet contains:

Tablets Trimethoprim BP 160mg

Sulfamethoxazole BP 800mg

576 Cetirizine Hydrochloride, Phenyl- Each uncoated tablet contains: propanolamine HCl & Para Tabs Cetirizine hydrochloride BP 5mg

Phenylpropanolamine Hydrochloride BP 10mg

Paracetamol BP 500mg

575 Levofloxacin Tablets 250mg Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Colour:Lake of sunset yellow FCF &

Titanium Dioxide BP

574 Levofloxacin Tablets 500mg Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 500mg Page 65 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour:Lake of sunset yellow FCF &

Titanium Dioxide BP

573 L-Ornithine L-Aspartate Each film coated tablet contains:

Tablets 150mg L-Ornithine L-Aspartate 150mg

Colour: Iron oxide Red & Titanium Dioxide BP

572 L-Ornithine L-Aspartate Each film coated tablet contains:

Tablets 500mg L-Ornithine L-Aspartate 500mg

Colour: Iron oxide Red & Titanium Dioxide BP

571 Atorvastatin Tablets 10mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 10mg

Colour: Black oxide Iron & Titanium Dioxide BP

570 Metformin Tablets IP 500mg Each uncoated tablet contains:

Metformin Hydrochloride IP 500mg

569 Glimepiride Tablets 2mg Each uncoated tablet contains:

Glimepiride USP 2mg

Colour: Sunset yellow FCF

568 Sparfloxacin Tablets 200mg Each film coated tablet contains:

Sparfloxacin 200mg

Excipients q.s.

Colour: Sunset yellow FCF&Titanium Dioxide IP

567 Tranexamic Acid & Mefenamic Each film coated tablet contains:

Acid Tablets Tranexamic Acid BP 500mg

Mefenamic Acid IP 250mg

Colour: Quinoline yellow

566 Pregabalin Capsules 75mg Each hard gelatin capsule contains: DCG (I) +

Pregabalin 75mg

Excipients q.s.

Approved colours used in capsule shell.

565 Calcium with Vitamin D3 Tablets Each film coated tablet contains:

Calcium Carbonate 1.250gm

eq. to elemental Calcium 500mg

Vitamin D3 IP 250 IU

Colour: Titanium Dioxide IP

Overages of vitamin added to compensate loss on storage.

564 Amlodipine Tablets 5mg Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 5mg

Colour: Iron Oxide Red

563 Levofloxacin Tablets 500mg Each film coated tablet contains: Page 66 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Levofloxacin Hemihydrate eq. to Levofloxacin 500mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide BP

562 Allupurinol Tablets BP 100mg Each uncoated tablet contains:

Allupurinol BP 100mg

561 Bisoprolol fumarate Tab USP 5mg Each film coated tablet contains:

Bisoprolol Fumarate USP 5mg

Colour: Iron oxide yellow &

Titanium Dioxide BP

560 Loratadine Tablets USP 10mg Each uncoated tablet contains:

Loratadine USP 10mg

559 Captopril Tablets BP 25mg Each uncoated tablet contains:

Captopril BP 25mg

558 Cetirizine Tablets 10mg Each film coated tablet contains:

Cetirizine hydrochloride BP 10mg

Colour: Titanium Dioxide BP

557 Cimetidine Tablets BP 400mg Each film coated tablet contains:

Cimetidine BP 400mg

Colour: titanium Dioxide BP

556 Meloxicam Tablets BP 7.5mg Each uncoated tablet contains:

Meloxicam BP 7.5mg

555 Tinidazole Tablets 500mg Each film coated tablet contains:

Tinidazole BP 500mg

Colour: Quinoline yellow

554 Nimesulide Tablets 100mg Each uncoated tablet contains:

Nimesulide BP 10mg

553 Acetylcysteine Capsules 200mg Each hard gelatin capsule contains:

Acetylcysteine BP 200mg

552 Alprazolam Tablets IP Each uncoated tablet contains:

Approved colours used in capsule shell.

Alprazolam IP 0.25mg

Colour: Tartrazine yellow

551 Alprazolam Tablets IP Each uncoated tablet contains:

Alprazolam IP 0.5mg

Colour: Sunset yellow

550 Alprazolam Tablets IP Each uncoated tablet contains:

Alprazolam IP 1.0mg

549 Topiramate Tablets Each filmcoated tablet contains:-

Colour: Tartrazine yellow

Topiramate 100mg Page 67 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

colours: Yellow oxide of Iron & Titanium

Dioxide IP

548 Atorvastatin Tablets I.P Each film coated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 40mg

Excipients q.s.

Colour: Titanium Dioxide IP

547 Ramipril Tablets 1.25mg Each uncoated tablet contains:

Ramipril IP 1.25mg

546 Ramipril Tablets 2.5mg Each uncoated tablet contains:

545 Ramipril Tablets 5mg Each uncoated tablet contains:

Ramipril IP 2.5mg

Ramipril IP 5mg

544 Rabeprazole Sodium Tabs 20mg Each enteric coated tablet contains:-

Rabeprazole Sodium 20mg colour: Yellow oxide of Iron &

Titanium Dioxide BP

543 Albendazole Tablets 400mg Each uncoated chewable tablet contains:

Albendazole BP 400mg

Colour: Sunset yellow supra

542 Norfloxacin Tablets BP 400mg Each film coated tablet contains:

Norfloxacin BP 400mg

541 Colchicine Tablets BP 1mg Each uncoated tablet contains:

Colchicine BP 1mg colour: Iron Oxide of Yellow

540 Celecoxib Capsules 100mg Each hard gelatin capsule contains:

Celecoxib 100mg

Approved colours used in capsule shell.

539 Celecoxib Capsules 200mg Each hard gelatin capsule contains:

Celecoxib 200mg

Approved colours used in capsule shell.

538 Fluconazole Capsules 150mg Each hard gelatin capsule contains:

Fluconazole USP 150mg

537 Lansoprazole Capsules 30mg Each hard gelatin capsule contains:

Lansoprazole USP 30mg

(as enteric coated granules)

Approved colours used in capsule shell.

536 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S (-) Amlodipine Besilate eq. to S (-) Amlodipine 1.25mg

Page 68 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Yellow Oxide of Iron

535 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S (-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Colour: Yellow Oxide of Iron

534 S(-) Amlodipine Besilate Tablets Each uncoated tablet contains:

S (-) Amlodipine Besilate eq. to S (-) Amlodipine 5mg

Colour: Yellow Oxide of Iron

533 S(-) Amlodipine & Atenolol Tabs Each uncoated tablet contains:

S (-) Amlodipine Besilate eq. to S(-) amlodipine 2.5mg

Atenolol IP 50mg

Colour: Lake of Sunset yellow

532 R-Ondansetron Hydrochloride Each dispersible tablet contains:

Dihydrate Dispersible Tablets R-Ondansetron Hydrochloride Dihydrate eq. to R-Ondansetron 2mg

531 R-Ondansetron Hydrochloride Each dispersible tablet contains:

Dihydrate Dispersible Tablets R-Ondansetron Hydrochloride Dihydrate eq. to R-Ondansetron 4mg

530 R-Ondansetron Hydrochloride Each 5ml contains:

Dihydrate Oral Solution R-Ondansetron Hydrochloride Dihydrate eq. to R-Ondansetron 1mg

529 Diazepam Tablets BP 10mg Each uncoated tablet contains:

Diazepam BP 10mg

Colour: Indigocarmine

528 Bisacodyl Tablets BP 5mg Each enteric coated tablet contains:-

Bisacodyl BP 5mg

527 Isosorbide Dinitrate Tabs BP 10mg Each uncoated tablet contains:

Isosorbide Dinitrate 10mg

(as diluted Isosorbide Dinitrate BP)

526 Sulfadoxine & Pyrimethamine Each uncoated tablet contains:

Tablets USP Sulfadoxine USP 500mg

Pyrimethamine USP 25mg

525 Diltiazem Hydrochloride Tabs Each film coated tablet contains:

USP 60mg Diltiazem Hydrochloride USP 60mg

524 Magnesium Trisilicate Tablets Each uncoated chewable tablet contains:

Magnesium Trisilicate BP 250mg

Dried Aluminium Hydroxide BP 120mg

523 Levofloxacin Tablets 500mg Each film coated tablet contains:

Levofloxacin Hemihydrate Page 69 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Levofloxacin 500mg

522 Aceclofenac Tablets 100mg Each film coated tablet contains:

Aceclofenac IP 100mg

Colour: Titanium Dioxide IP

521 Chloroquine Phosphate Each film coated tablet contains:

Tablets BP 250mg Chloroquine Phosphate BP 250mg

520 Ethambutol Tablets BP 400mg Each film coated tablet contains:

Ethambutol Hydrochloride BP 400mg

519 Isoniazid Tablets BP 100mg Each uncoated tablet contains:

Isoniazid BP 100mg

518 Pyrazinamide Tabs IP 1500mg Each uncoated tablet contains:

Pyrazinamide IP 1500mg

517 Pyrazinamide Tabs IP 500mg Each uncoated tablet contains:

Pyrazinamide IP 500mg

516 Ramipril Capsules 2.5mg Each hard gelatin capsule contains:

Ramipril BP 2.5mg

Excipients q.s.

Approved colours used in capsule shell.

515 Ramipril Capsules 5mg Each hard gelatin capsule contains:

Ramipril BP 5mg

Excipients q.s.

Approved colours used in capsule shell.

514 Calcium Dobesilate Monohydrate Each hard gelatin capsule contains:

Capsules Calcium Dobesilate monohydrate BP eq. to anhydrous calcium dobesilate 500mg

513 Topiramate Tablets Each film coated tablet contains:

Approved colours used in capsule shell.

Topiramate USP 100mg

Excipients q.s.

Colour: Yellow oxide of Iron & Titanium

Dioxide IP

512 Theophylline & Pyridoxine HCl Each uncoated controlled release tablet

Controlled Release Tablets contains:

Theophylline (anhydrous) IP 400mg

Pyridoxine Hydrochloride IP 25mg

511 Theophylline & Pyridoxine HCl Each uncoated controlled release tablet

Controlled Release Tablets contains:

Theophylline (anhydrous) IP 600mg

Pyridoxine Hydrochloride IP 25mg

Overages of vitamin added to compensate loss on storage.

Page 70 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

510 Ondansetron DT Tablets Each uncoated dispersible tablet NA contains:

Ondansetron 4mg

As Ondansetron Hydrochloride USP

509 Flavoxate HCl & Ofloxacin Tabs Each film coated tablet contains:

Flavoxate Hydrochloride BP 200mg

Ofloxacin USP 200mg

Colour: Titanium Dioxide IP

508 Ondansetron Tablets 4mg Each film coated tablet contains:

Ondansetron Hydrochloride USP

(as Dihydrate) eq. to Ondansetron 4mg

507 Betahistine dihydrochloride Each uncoated dispersible tablet contains:

Dispersible Tablets Betahistine dihydrochloride IP 8mg

Colour: Lake of Quinoline yellow WS

506 Betahistine dihydrochloride Each uncoated dispersible tablet contains:

Dispersible Tablets Betahistine dihydrochloride IP 16mg

Colour: Lake of Sunset yellow FCF

505 Torsemide Tablets 5mg Each uncoated tablet contains:

Torsemide USP 5mg

Excipients q.s.

504 Torsemide Tablets 10mg Each uncoated tablet contains:

Torsemide USP 10mg

Excipients q.s.

503 Torsemide Tablets 20mg Each uncoated tablet contains:

Torsemide USP 20mg

Excipients q.s.

502 Diclofenac Potassium & Each film coated tablet contains:

Metaxalone Tablets Diclofenac Potassium BP 50mg

Metaxalone 400mg

Colour: Lake of Sunset Yellow FCF

501 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac BP 100mg

Paracetamol BP 650mg

Colour: Quinoline yellow

500 Aceclofenac sustained Release tab Each film coated sustained release tablet contains:

Aceclofenac BP 200mg

Colour: Titanium Dioxide IP

499 Pantoprazole Tablets Each enteric coated tablet contains:-

Pantoprazole Sodium Sesquihydrate Page 71 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Pantoprazole 40mg colour: Yellow Iron Oxide & Titanium

Dioxide IP

498 Pantoprazole & domperidone Tab Each enteric coated tablet contains:-

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 40mg

Domperidone BP 20mg

Colour: Titanium dioxide IP & Yellow

Oxide or Iron

497 L-Carnitine L-Tartrate Tablets Each film coated tablet contains:

L-Carnitine L-Tartrate 725mg eq. to L-Carnitine 500mg

Colour: Titanium Dioxide IP

496 Diacerein Capsules Each hard gelatin capsule contains:

Diacerein 50mg

Approved colours used in capsule shell.

495 R-Ondansetron Hydrochloride Each dispersible tablet contains:

Dihydrate Dispersible Tablets R-Ondansetron Hydrochloride Dihydrate eq. to R-Ondansetron 2mg

494 R-Ondansetron Hydrochloride Each dispersible tablet contains:

Dihydrate Dispersible Tablets R-Ondansetron Hydrochloride Dihydrate eq. to R-Ondansetron 4mg

493 R-Ondansetron Hydrochloride Each 5ml contains:

Dihydrate Oral Solution R-Ondansetron Hydrochloride Dihydrate eq. to R-Ondansetron 1mg

492 Amlodipine Besilate Tablets Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 5mg

Colour: Red Oxide of Iron

491 Atenolol Tablets IP Each uncoated tablet contains:

Atenolol IP 25mg

490 Losartan Potassium Tablets Each film coated tablet contains:

Losartan Potassium USP 50mg

Excipients q.s.

colour: Titanium Dioxide IP

489 Losartan Potassium & Each film coated tablet contains:

Hydrochlorothiazide Tablets Losartan Potassium USP 50mg

Hydrochlorothiazide IP 12.5mg

colour: Lake of Quinoline yellow WS &

Titanium Dioxide IP

488 Ciprofloxacin Tablets IP Each film coated tablet contains: Page 72 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Ciprofloxacin 500mg

As Ciprofloxacin Hydrochloride IP

Colour: Lake of Ponceau 4R &

Titanium Dioxide IP

487 MSM & Glucosamine Tablets Each film coated tablet contains:

Glucosamine Sulphate Potassium

Chloride USP 750mg

MSM 250mg

486 Pantoprazole Tablets Each enteric coated tablet contains:-

Pantoprazole 40mg

As Pantoprazole Sodium Sesquihydrate

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

485 Betahistine dihydrochloride Each uncoated chewable tablet contains:

Dispersible Tablets Betahistine Dihydrochloride IP 24mg

Colour: Tartrazine Yellow Lake

484 Aceclofenac & Paracetamol Tabs Each uncoated tablet contains:

Aceclofenac BP 100mg

Paracetamol IP 500mg

483 Metformin HCl ER Tablets Each uncoated extended release tablet NA contains:

Metformin Hydrochloride IP 500mg

482 Metformin HCl Tablets IP 500mg Each uncoated tablet contains: NA

Metformin Hydrochloride IP 500mg

481 Betahistine dihydrochloride Each uncoated dispersible tablet contains: NA

Dispersible Tablets Betahistine Dihydrochloride 8mg

Colour: Lake of quinoline yellow WS

480 Betahistine dihydrochloride Each uncoated dispersible tablet contains: NA

Dispersible Tablets Betahistine Dihydrochloride 16mg

Colour: Lake of sunset yellow WS

479 Amlodipine Besilate & Atenolol Each uncoated tablet contains: NA

Tablets Amlodipine Besilate BP eq. to Amlodipine 5mg

Atenolol IP 50mg

478 Orlistat Capsules 120mg Each hard gelatin capsule contains:

Orlistat 120mg

Approved colours used in capsule shell.

477 Drotaverine HCl Tablets 80mg Each film coated tablet contains:

Drotaverine Hydrochloride 80mg

476 Tranexamic Acid Tablets Each film coated tablet contains:

Tranexamic Acid BP 500mg Page 73 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Titanium Dioxide IP

475 Drotaverine HCl Tablets 40mg Each film coated tablet contains:

Drotaverine Hydrochloride 40mg

474 Clonazepam Dispersible Each uncoated dispersible tablet contains:

Tablets 0.25mg Clonazepam USP 0.25mg

Colour: Quinoline yellow WS

473 Clonazepam Dispersible Each uncoated dispersible tablet contains:

Tablets 0.50mg Clonazepam USP 0.50mg

Colour: Ponceau 4R

472 Tamsulosin Hydrochloride & Each film coated tablet contains:

Finasteride Tablets Tamsulosin Hydrochloride 0.4mg

(as sustained release0

Finasteride USP 5mg

Colour: Red Oxide of Iron &

Titanium Dioxide IP

471 Nimesulide Tablets 100mg Each uncoated tablet contains:

Nimesulide BP 100mg colour: Lake of Quinoline yellow

470 Nimesulide & Paracetamol Tabs Each uncoated tablet contains:

Nimesulide BP 100mg

Paracetamol IP 325mg

469 Aceclofenac Tablets IP 100mg Each film coated tablet contains:

Aceclofenac IP 100mg

Colour: Titanium Dioxide IP

468 Aceclofenac & Paracetamol Tabs Each film coated tablet contains:

Aceclofenac IP 100mg

Paracetamol IP 500mg

Colour: Titanium Dioxide IP

467 S (-) Amlodipine & Losartan Each uncoated tablet contains:

Potassium Tablets S (-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Losartan Potassium IP 50mg

Colour: Lake of quinoline yellow

466 S (-) Amlodipine & Atenolol Tabs Each uncoated tablet contains:

S (-) Amlodipine Besilate eq. to S (-) Amlodipine 2.5mg

Atenolol IP 50mg

Colour: Lake of Sunset yellow

465 S (-) Amlodipine & Atenolol Tabs Each uncoated tablet contains:

S (-) Amlodipine Besilate eq. to S (-) Amlodipine 5mg Page 74 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Atenolol IP 50mg

Colour: Lake of Sunset yellow

464 Esomeprazole & Domperidone tab Each enteric coated tablet contains:-

Esomeprazole Magnesium Trihydrate eq. to Esomeprazole 20mg

Domperidone BP 10mg colour: Lake of Indigocarmine &

Titanium Dioxide IP

463 Nitazoxanide & Ofloxacin Tabs Each film coated tablet contains:

Nitazoxanide 500mg

Ofloxacin USP 200mg

Colour: Lake of quinoline yellow WS &

Titanium Dioxide IP

462 Metformin Hydrochloride ER Tab Each uncoated extended release tablet

Metformin Hydrochloride IP 1000mg

461 Ofloxacin Dispersible Tablets Each uncoated dispersible tablet contains:

Ofloxacin USP 50mg

Colour: Erythrosine

460 Clonazepam Dispersible Tabs Each uncoated dispersible tablet contains:

Clonazepam USP 0.25mg

Colour: Yellow Oxide of Iron

459 Clonazepam Dispersible Tabs Each uncoated dispersible tablet contains:

Clonazepam USP 0.50mg

Colour: Ponceau 4R

458 Rabeprazole Sodium Tablets Each enteric coated tablet contains:- NA

Rabeprazole Sodium 20mg

Colour: Yellow Oxide of Iron

457 Amlodipine Besilate & Each film coated tablet contains:

Hydrochlorothiazide Tablets Amlodipine Besilate BP eq. to Amlodipine 5mg

Hydrochlorothiazide IP 12.5mg

456 Levofloxacin & Ornidazole Tabs Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Ornidazole 500mg

Colour: Red oxide of Iron & Titanium

Dioxide IP

455 Amlodipine & Losartan Pot. Tabs Each film coated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 5mg

Losartan Potassium USP 50mg Page 75 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Lake of quinoline yellow &

Titanium Dioxide IP

454 Omeprazole Magnesium & Each enteric coated tablet contains:-

Domperidone Tablets Omeprazole Magnesium eq. to Omeprazole 10mg

Domperidone BP 15mg

453 Aceclofenac Tablets Each film coated tablet contains:

Aceclofenac BP 100mg colour: titanium Dioxide IP

452 Levofloxacin Tablets Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 500mg

Colour: Titanium Dioxide IP

451 Cinnarizine Tablets 25mg Each uncoated mouth dissolving tablet contains

Cinnarizine IP 25mg

Colour: Lake of sunset yellow FCF

450 Cinnarizine Tablets 75mg Each uncoated mouth dissolving tablet contains

Cinnarizine IP 75mg

Colour: Lake of quinoline yellow WS

449 Cinnarizine & Domperidone Each uncoated tablet contains:

Maleate Tablets Cinnarizine IP 20mg

Domperidone Maleate BP eq. to Domperidone 15mg

448 Artesunate Tablets Each uncoated tablet contains:

Artesunate 50mg

Colour: Sunset yellow FCF &

Titanium Dioxide

447 Tranexamic Acid Tablets 500mg Each fim coated tablet contains:

Tranexamic Acid BP 500mg

446 Tranexamic Acid Tablets 1000mg Each film coated tablet contains:

Tranexamic Acid BP 1000mg

445 Amlodipine Tablets 5mg Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 5mg

444 Amlodipine & Atenolol Tablets Each uncoated tablet contains:

Amlodipine Besilate BP eq. to Amlodipine 5mg

Atenolol IP 50mg

443 Microcrystalline Hydroxyapatitie Each film coated tablet contains: Page 76 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS complex, Calcium, Phosphorous Microcrystalline Hydroxyapatite

Tablets Complex (M.C.H.C.) Providing

Calcium 200mg

Phosphorous 100mg

Excipients q.s.

Colour: Sunset yellow FCF

442 Domperidone & Pantoprazole Each enteric coated tablet contains:-

Tablets Domperidone BP 10mg

Pantoprazole Sodium Sesquihydrate eq. to Pantoprazole 20mg

441 Diclofenac Potassium & Each film coated tablet contains:

Dicyclomine Tablets Diclofenac Potassium BP 50mg

Dicyclomine Hydrochloride IP 20mg

440 Etamsylate Tablets Each uncoated tablet contains:

Etamsylate BP 500mg

439 Doxofylline Syrup Each 5ml contains:

438 Levocetirizine & Ambroxol Syrp. Each 5ml contains:

Doxofylline 100mg

Levocetirizine Hydrochloride IP 5mg

Ambroxol Hydrochloride IP 30mg flavoured syrupy base q.s.

Colour: Ponceau 4R supra

437 Doxofylline Tablets 400mg Each uncoated tablet contains:

Doxofylline 400mg

436 Gemifloxacin Mesylate Tab 320mg Each film coated tablet contains:

Gemifloxacin Mesylate eq. to Gemifloxacin 320mg colour: Yellow Oxide of Iron &

Titanium Dioxide IP

435 Ranolazine Extended Release Tab Each film coated extended release tablet contains

Ranolazine 500mg

Colour: Sunset yellow FCF &

Titanium Dioxide

434 Glucosamine Sulphate Potassium Each film coated tablet contains:

Chloride, MSM & Diacerein Tabs Glucosamine Sulphate Potassium

Chloride USP 750mg

Methyl Sulphonyl Methane 250mg

Diacerein 50mg

Colour: Quinoline yellow

433 Montelukast Sodium & Each film coated tablet contains: Page 77 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Levocetirizine HCl Tablets Montelukast sodium

Equivalent to Montelukast 10mg

Levocetirizine Hydrochloride IP 5mg

Colour: Yellow Oxide of Iron

432 Diacerein Tablets Each film coated tablet contains:

Diacerein 50mg

Colour: Quinoline yellow

431 Nitroglycerine Controlled Each uncoated tablet contains:

Release Tablets Diluted Nitroglycerine USP

Equivalent to Nitroglycerine 2.6mg

(In a controlled release system)

Colour: Erythrosine Lake

430 Nitroglycerine Controlled Each uncoated tablet contains:

Release Tablets Diluted Nitroglycerine USP

Equivalent to Nitroglycerine 6.4mg

(In a controlled release system)

Colour: Erythrosine Lake

429 Diacerein Capsules Each hard gelatin capsule contains:

Diacerein 50mg

Approved colours used in capsule shell.

428 Orlistat Capsules 120mg Each hard gelatin capsule contains:

Orlistat 120mg

Approved colours used in capsule shell.

427 Omeprazole capsules 20mg Each hard gelatin capsule contains:

Omeprazole IP 20mg

(as enteric coated granules)

Approved colours used in capsule shell.

426 Omeprazole capsules 10mg Each capsule contains:

Omeprazole IP 10mg

(as enteric coated granules)

Approved colours used in capsule shell.

425 Omeprazole capsules 20mg Each capsule contains:

Omeprazole IP 20mg

(as enteric coated granules)

Approved colours used in capsule shell.

424 Ramipril Capsules BP 1.25mg Each hard gelatin capsule contains: NA

Ramipril BP 1.25mg

Approved colours used in capsule shell.

423 Ramipril Capsules BP 2.5mg Each hard gelatin capsule contains: NA

Ramipril BP 2.5mg

Approved colours used in capsule shell.

Page 78 of 252

NA

NA

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

422 Ramipril Capsules BP 5mg Each hard gelatin capsule contains: NA

Ramipril BP 5mg

Approved colours used in capsule shell.

421 Ondansetron Oral Solution USP Each 5ml contains:

Ondansetron Hydrochloride USP

(as Dihydrate)

Equivalent to Ondansetron 2mg

420 Ambroxol, Terbutaline, Each 5ml contains:

Guaiphenesin & Menthol syrup Ambroxol Hydrochloride BP 15mg

Terbutaline sulphate IP 1.25mg

Guaiphenesin IP 50mg

419 Dextromethophan, Triprolidione, Each 5ml contains:

Menthol IP 2.5mg

flavoured syrupy base q.s.

Pseudoephedrine & Menthol Dextromethorphan HBr IP 10mg

Syrup Triprolidine Hydrochloride IP 1.25mg

Pseudoephedrine HCl IP 30mg

Menthol IP 1.5mg

418 Pyrantel Pamoate Oral Susp. USP Each ml contains:

In flavoured syrup base

Pyrantel Pamoate USP

Equivalent to Pyrantel 25mg

In flavoured syrup base

417 Tramadol Control Release Tabs Each film coated tablet contains:

Tramadol Hydrochloride BP 50mg

(In a controlled release system)

Colour: Iron Oxide yellow

416 Tramadol hydrochloride & Each film coated tablet contains:

Paracetamol Tablets Tramadol Hydrochloride BP 37.5mg

Paracetamol IP 325mg

Colour: Sunset yellow Lake

415 Diclofenac Potassium,Paracetamol Each film coated tablet contains: and Famotidine Tablets Diclofenac Potassium BP 50mg

Paracetamol IP 325mg

Famotidine USP 20mg

Colour: Indigocarmine &

Titanium Dioxide IP

414 Ibuprofen, Paracetamol & Each film coated tablet contains:

Famotidine Tablets Ibuprofen IP 400mg

Paracetamol IP 325mg

Famotidine USP 20mg Page 79 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Ponceau 4R& Titaniumd Dioxide IP

413 Citalopram Tablets USP Each film coated tablet contains:

Citalopram Hydrobromide USP

Equivalent to Citalopram 10mg

Excipients q.s.

colour: Iron Oxide of Red &

Iron Oxide of Yellow

412 Citalopram Tablets USP Each film coated tablet contains:

Citalopram Hydrobromide USP

Equivalent to Citalopram 20mg

Excipients q.s.

colour: Brilliant blue FCF &

Quinoline yellow

411 Citalopram Tablets USP Each film coated tablet contains:

Citalopram Hydrobromide USP

Equivalent to Citalopram 40mg

Excipients q.s.

Colour: Erythrosine

410 Amitriptyline Tablets IP Each film coated tablet contains:

Amitriptyline Hydrochloride IP 25mg

Excipients q.s.

Colour: Lake of Erythrosine

409 Amitriptyline Tablets IP Each film coated tablet contains:

Amitriptyline Hydrochloride IP 50mg

Excipients q.s.

Colour: Lake of Tartrazine

408 Amitriptyline Tablets IP Each film coated tablet contains:

Amitriptyline Hydrochloride IP 75mg

Excipients q.s.

Colour: Lake of Brilliant blue &

Lake of Tartrazine

407 Diacerein Capsules Each hard gelatin capsule contains:

Diacerein 50mg

Approved colours used in capsule shell.

406 Ofloxacin & Ornidazole Tablets Each film coated tablet contains:

Ofloxacin IP 200mg

Ornidazole 500mg

Colour: Titanium Dioxide IP

405 Ofloxacin & Ornidazole Tablets Each film coated tablet contains:

Ofloxacin IP 200mg

Ornidazole 500mg Page 80 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS colour: Titanium Dioxide IP

404 Ambroxol Hydrochloride, Each 5ml contains:

Terbutaline Sulphate, Guaiphe- Ambroxol Hydrochloride IP 30mg nesin & Menthol Expectorant Terbutaline sulphate IP 1.5mg

Guaiphenesin IP 50mg

Menthol IP 0.5mg

In flavoured syrup base

Colour: Sunset yellow & Erythrosine

403 Lornoxicam Tablets 4mg Each film coated tablet contains:

Lornoxicam 4mg colour: Quinoline yellow lake &

Titanium Dioxide IP

402 Lornoxicam Tablets 8mg Each film coated tablet contains:

Lornoxicam 8mg colour: Quinoline yellow lake &

Titanium Dioxide IP

401 L-Ornithine L-Aspartate Tabs Each film coated tablet contains:

L-Ornithine L-Asparate 500mg

Colour: Iron Oxide of Red &

Titanium Dioxide BP

400 Gatifloxacin Sesquihydrate Tabs Each film coated tablet contains:

Gatifloxacin Sesuihydrate

Eq. to Gatifloxacin 200mg colour: Lake of Quinoline yellow &

Titanium Dioxide BP

399 Sumatriptan Tablets BP 50mg Each film coated tablet contains:

Sumatriptan Succinate BP

Eq. to Sumatriptan 50mg colour: Tartrazine lake

398 Nimodipine Tablets BP 50mg Each film coated tablet contains:

Nimodipine BP 50mg colour: Iron Oxide of Yellow

397 Gabapentin Capsules Each hard gelatin capsule contains:

Gabapentin USP 100mg

Approved colours used in capsule shell.

396 Lorazepam Tablets BP Each uncoated tablet contains:

Lorazepam BP 1mg

Excipients q.s.

Colour: Sunset yellow FCF

395 Lorazepam Tablets BP Each uncoated tablet contains:

Lorazepam BP 2mg Page 81 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

Colour: Tartrazine

394 Nortriptyline Hydrochloride Each film coated tablet contains:

Tablets IP Nortriptyline Hydrochloride IP

Eq. to Nortriptyline 25mg

Excipients q.s.

Colour: Lake of Erythrosine

393 Clomipramine Tablets Each film coated tablet contains:

Clomipramine Hydrochloride BP 25mg

Excipients q.s.

colour: Lake of Carmosine

392 Clomipramine Tablets Each film coated tablet contains:

Clomipramine Hydrochloride BP 50mg

Excipients q.s.

Colour: Lake of Brilliant blue

391 Sertraline Hydrochloride Tablets Each film coated tablet contains:

Sertraline Hydrochloride

Eq. to Sertraline 25mg

Excipients q.s.

Colour: Lake of Brilliant blue & lake of

Erythrosine

390 Sertraline Hydrochloride Tablets Each film coated tablet contains:

Sertraline Hydrochloride

Eq. to Sertraline 50mg

Excipients q.s.

Colour: Iron Oxide of Yellow

389 Sertraline Hydrochloride Tablets Each film coated tablet contains:

Sertraline Hydrochloride

Eq. to Sertraline 100mg

Excipients q.s.

Colour: Iron Oxide of Red

388 Chlordiazepoxide &Amitriptyline Each film coated tablet contains:

Hydrochloride Tablets USP Chlordiazepoxide IP 10mg

Amitriptyline Hydrochloride IP

Eq. to Amitriptyline 25mg

Excipients q.s.

Colour: Lake of Erythrosine

387 Chlordiazepoxide &Amitriptyline Each film coated tablet contains:

Hydrochloride Tablets USP Chlordiazepoxide IP 5mg

Amitriptyline Hydrochloride IP

Eq. to Amitriptyline 12.5mg

Page 82 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

colour: Lake of Indigocarmine

386 Amoxapine Tablets USP Each uncoated tablet contains:

Amoxapine USP 50mg

Excipients q.s.

385 Amoxapine Tablets USP Each uncoated tablet contains:

Amoxapine USP 100mg

Excipients q.s.

384 Mirtazapine Tablets USP Each film coated tablet contains:

Mirtazapine USP 7.5mg

Excipients q.s.

Colour: Quinoline yellow

383 Mirtazapine Tablets USP Each film coated tablet contains:

Mirtazapine USP 15mg

Excipients q.s.

Colour: Yellow Oxide of Iron

382 Mirtazapine Tablets USP Each film coated tablet contains:

Mirtazapine USP 30mg

Excipients q.s.

Colour: Red Oxide of Iron

381 Voglibose Tablets 0.2mg Each uncoated tablet contains:

Voglibose 0.2mg

Excipients q.s.

380 Voglibose Tablets 0.3mg Each uncoated tablet contains:

Voglibose 0.3mg

Excipients q.s.

379 Ondansetron Mouth Each uncoated mouth dissolving

Dissolving Tablets tablet contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

378 Ciprofloxacin Tablets IP 750mg Each film coated tablet contains:

Ciprofloxacin Hydrochloride IP

Eq. to Ciprofloxacin 750mg

Colour: Lake of Ponceau 4R &

Titanium Dioxide IP

377 Olanzapine Tablets IP Each film coated tablet contains:

Olanzapine IP 2.5mg

Excipients q.s.

colour: Lake of Ponceau 4R

376 Olanzapine Tablets IP Each film coated tablet contains:

Olanzapine IP 5mg Page 83 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

colour: Lake of Indigocarmine

375 Olanzapine Tablets IP Each film coated tablet contains:

Olanzapine IP 7.5mg

Excipients q.s.

Colour: Lake of Tartrazine

374 Olanzapine Tablets IP Each film coated tablet contains:

Olanzapine IP 10mg

373 Risperidone Tablets Each film coated tablet contains:

Excipients q.s.

Colour: Lake of Erythrosine

372 Risperidone Tablets Each film coated tablet contains:

Risperidone BP 1mg

Excipients q.s.

Colour: Titanium Dioxide IP

Risperidone BP 2mg

Excipients q.s.

Colour: Lake of Ponceau 4R

371 Risperidone Tablets Each film coated tablet contains:

Risperidone BP 3mg

Excipients q.s.

Colour: Lake of Quinoline yellow

370 Risperidone Tablets Each film coated tablet contains:

Risperidone BP 4mg

Excipients q.s.

Colour: Lake of Sunset yellow

369 Captopril Tablets BP 25mg Each unocated tablet contains:

Captopril BP 25mg

368 Cimetidine Tablets BP 400mg Each film coated tablet contains:

Cimetidine BP 400mg

Colour: Titanium Dioxide BP

367 Ibuprofen Tablets BP 400mg Each film coated tablet contains:

Ibuprofen BP 400mg

Colour: Lake of Erythrosine & Titanium

Dioxide BP

366 Salbutamol Tablets BP 4mg Each uncoated tablet contains:

Salbutamol Sulphate BP eq. to Salbutamol 4mg

365 Prednisolone Tablets BP 5mg Each uncoated tablet contains:

Prednisolone BP 5mg

Colour: Quinoline yellow Page 84 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

364 Metformin Tablets BP 500mg Each film coated tablet contains:

Metformin Hydrochloride BP 500mg

Colour: Titanium Dioxide BP

363 Hydrochlorothiazide Tablets Each film coated tablet contains:

BP 25mg Hydrochlorothiazide BP 25mg

Colour: Titanium Dioxide BP

362 Griseofulvin Tablets BP 125mg Each uncoated tablet contains:

Griseofulvin BP 125mg

361 Griseofulvin Tablets BP 500mg Each uncoated tablet contains:

Griseofulvin BP 500mg

360 Diclofenac sodium & Paracetamol Each uncoated tablet contains:

Tablets Diclofenac Potassium BP 50mg

Paracetamol BP 500mg

359 Nifedipine Extended Release Each extended release tablet contains:

Tablets USP 20mg Nifedipine USP 20mg

358 Slow Diclofenac Tablets BP 75mg Each film coated sustained release tablet contains:

Diclofenac Sodium BP 75mg

Colour: Titanium Dioxide BP & Ponceau 4R

357 Slow Diclofenac Tablets BP 100mg Each film coated sustained release tablet contains:

Diclofenac Sodium BP 100mg

Colour: Titanium Dioxide BP & Ponceau 4R

356 Sildenafil Citrate Tablets 50mg Each film coated tablet contains:

Sildenafil Citrate eq. to Sildenafil 50mg

Colour: Lake of Indigocarmine, Titanium

Dioxide BP

355 Atorvastatin & Ezetimibe Tablets Each film coated tablet contains:

Atorvastatin Calcium 10mg

Ezetimibe 10mg

Colour: Sunset yellow & Titanium

Dioxide BP

354 Chloamphenicol Palmitate Oral Each 5ml contains:

Suspension USP Chloramphenicol Palmitate USP

Eq. to Chloramphenicol 125mg

353 Salbutamol Oral Solution BP Each 5ml contains:

Salbutamol Sulphate BP eq. to Salbutamol 2mg

352 Lornoxicam Tablets 4mg Each film coated tablet contains: DCG (I) +

Lornoxicam 4mg Page 85 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS colour: Quinoline yellow lake &

Titanium Dioxide IP

351 Lornoxicam Tablets 8mg Each film coated tablet contains: DCG (I) +

Lornoxicam 8mg colour: Quinoline yellow lake &

Titanium Dioxide IP

350 Eszopicione Tablets 1mg Each film coated tablet contains:

Eszopicione 1mg

Colour: Titanium Dioxide IP

349 Eszopicione Tablets 2mg Each film coated tablet contains:

Eszopicione 2mg

Colour: Titanium Dioxide IP

348 Eszopicione Tablets 3mg Each film coated tablet contains:

Eszopicione 3mg

Colour: Titanium Dioxide IP

347 Ivermectin Dispersible Tabs 3mg Each uncoated dispersible tablet contains:

Ivermectin BP 3mg

346 Ivermectin Tablets 12mg Each uncoated tablet contains:

Ivermectin BP 12mg

345 Ofloxacin Dispersible Tabs 100mg Each uncoated dispersible tablet contains:

Ofloxacin IP 100mg

344 Ofloxacin Tablets IP 200mg Each filmcoated tablet contains:

Ofloxacin IP 200mg

Colour: Red Oxide of Iron

343 Amiodarone I.V. Infusion BP Each ml contains:

Amiodarone Hydrochloride BP 50mg

Benzyl Alcohol BP 2% v/v

(as preservative)

Water for Injection BP q.s

342 Duloxetine Tablets 20mg Each enteric coated tablet contains:-

Duloxetine Hydrochloride eq. to Duloxetine 20mg

Colour: Titanium Dioxide IP

341 Duloxetine Tablets 30mg Each enteric coated tablet contains:-

Duloxetine Hydrochloride eq. to Duloxetine 30mg

Colour: Titanium Dioxide IP

340 Duloxetine Tablets 40mg Each enteric coated tablet contains:-

Duloxetine Hydrochloride eq. to Duloxetine 40mg

Colour: Titanium Dioxide IP Page 86 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

339 Duloxetine Tablets 60mg Each enteric coated tablet contains:-

Duloxetine Hydrochloride eq. to Duloxetine 60mg

Colour: Titanium Dioxide IP

338 Escitalopram Oxalate & Each film coated tablet contains:

Clonazepam Tablets Escitalopram Oxalate

Eq. to Escitalopram 10mg

Clonazepam IP 0.5mg

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

337 Phenylepherine Hydrochloride, Each ml contains:

Paracetamol & Chlorpheniramine, Phenylepherine Hydrochloride IP 2.5mg

Maleate Drops Paracetamol IP 125mg

Chlorpheniramine Maleate IP 1mg flavoured syrupy base q.s.

Colour: Erythrosine

336 Nicorandil Tablets Each uncoated tablet contains:

Nicorandil 10mg

335 Nimodipine Tablets BP Each film coated tablet contains:

Nimodipine BP 50mg

Colour: Titanium Dioxide BP

334 Metformin Sustained Release Tabs Each sustained release tablet contains:

Metformin Hydrochloride BP 1.0gm

333 Doxofyline Tablets Each uncoated tablet contains:

Doxofyline 400mg

332 Minoxidil Tablets USP 2.5mg Each uncoated tablet contains:

Minoxidil USP 2.5mg

331 Ethosuximide Capsules BP 250mg Each hard gelatin capsule contains:

Ethosuximide BP 250mg

330 Glucosamine Sulphate Potassium Each film coated tablet contains:

Chloride, MSM & Diacerein Tabs Glucosamine Sulphate Potassium

Chloride USP 750mg

MSM 250mg

Diacerein 50mg

Colour: Quinoline yellow

329 Ciprofloxacin HCl Tabs IP 750mg Each film coated tablet contains:

Ciprofloxacin Hydrochloride IP

Eq. to Ciprofloxacin 750mg

Colour: Ponceau 4R&Titaniumd Dioxide IP

328 Norfloxacin Tablets IP 200mg Each film coated tablet contains:

Norfloxacin IP 200mg Page 87 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Quinoline Yellow &

Titanium Dioxide IP

327 Metformin Hydrochloride Tabs IP Each uncoated tablet contains:

Metformin Hydrochloride IP 500mg

326 (R) - Sibutramine Hydrochloride Each hard gelatin capsule contains:

Monohydrate caps 2.5mg (R) - Sibutramine Hydrochloride monohydrate 2.5mg

Approved colours used in capsule shell.

325 (R) - Sibutramine Hydrochloride Each hard gelatin capsule contains:

Monohydrate caps 5mg (R) - Sibutramine Hydrochloride monohydrate 5mg

Approved colours used in capsule shell.

324 Dexibuprofen Tablets 300mg Each film coated tablet contains:

Dexibuprofen 300mg

Colour: Titanium Dioxide BP

323 Dexibuprofen Tablets 400mg Each film coated tablet contains:

Dexibuprofen 400mg

Colour: Titanium Dioxide BP

322 Aceclofenac, Paracetamol & Each film coated tablet contains:

Chlorzoxazone Tablets Aceclofenac IP 100mg

Paracetamol IP 500mg

Chlorzoxazone USP 500mg

Excipients q.s.

colour: Lake of Sunset yellow FCF

321 Pioglitazone Hydrochloride Tabs Each uncoated tablet contains:

Pioglitazone Hydrochloride

Eq. to Pioglitazone 15mg

320 Pioglitazone Hydrochloride Tabs Each uncoated tablet contains:

Pioglitazone Hydrochloride

Eq. to Pioglitazone 30mg

319 Glimepiride & Metformin (SR) Each film coated tablet contains:

Tablets Glimepiride USP 1mg

Metformin Hydrochloride IP 500mg

(in sustained release form)

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

318 Glimepiride & Metformin (SR) Each film coated tablet contains:

Tablets Glimepiride USP 2mg

Metformin Hydrochloride IP 500mg

(in sustained release form)

Colour: Red Oxide of Iron & Page 88 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Titanium Dioxide IP

317 Glimepiride, Pioglitazone & Each uncoated bilayered tablet contains:

Metformin (ER) Tablets Glimepiride USP 1mg

Pioglitazone Hydrochloride

Eq. to Pioglitazone 15mg

Metfromin Hydrochloride IP 500mg

(in extended release form)

Colour: Erythrosine

316 Glimepiride, Pioglitazone & Each uncoated bilayered tablet contains:

Metformin (ER) Tablets Glimepiride USP 2mg

Pioglitazone Hydrochloride

Eq. to Pioglitazone 15mg

Metfromin Hydrochloride IP 500mg

(in extended release form) colour: Brilliant blue FCF

315 Drotaverine Hydrochloride & Each film coated tablet contains:

Nimesulide Tablets Drotaverine Hydrochloride 40mg

Nimesulide BP 100mg

Colour:Quinoline yellow WS, Brilliant blue

FCF & Titanium Dioxide IP

314 Omeprazole Magnesium & Each enteric coated tablet contains:-

Dicyclomine HCl Tablets Omeprazole Magnesium eq. to Omeprazole 10mg

Dicyclomine Hydrochloride IP 20mg

Colour: Quinoline yellow WS &

Titanium Dioxide IP

313 Olanzapine Mouth Dissolving Each uncoated mouth dissolving

Tablets tablet contains:

Olanzapine IP 2.5mg

Excipients q.s.

312 Olanzapine Mouth Dissolving Each uncoated mouth dissolving

Tablets tablet contains:

Olanzapine IP 5mg

Excipients q.s.

311 Olanzapine Mouth Dissolving Each uncoated mouth dissolving

Tablets tablet contains:

Olanzapine IP 7.5mg

Excipients q.s.

310 Olanzapine Mouth Dissolving Each uncoated mouth dissolving

Tablets tablet contains:

Olanzapine IP 10mg Page 89 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Excipients q.s.

309 Pioglitazone & Metformin HCl Each film coated tablet contains:

(Sustained release) Tablets Pioglitazone Hydrochloride

Eq. to Pioglitazone 15mg

Metformin Hydrochloride IP 500mg

(in sustained release form)

Colour: Titanium Dioxide IP

308 Pioglitazone & Metformin HCl Each film coated tablet contains:

(Sustained release) Tablets Pioglitazone Hydrochloride

Eq. to Pioglitazone 30mg

Metformin Hydrochloride IP 500mg

(in sustained release form)

Colour: Lake of Tartrazine &

Titanium Dioxide IP

307 Drotaverine Hydrochloride & Each film coated tablet contains:

Mefenamic Acid Tablets Drotaverine Hydrochloride 80mg

Mefenamic Acid IP 250mg

Colour: Lake of Quinoline yellow &

Titanium Dioxide IP

306 Chlorpheniramine Maleate, Each 5ml contains:

Codeine Phosphate & Chlorpheniramine Maleate IP 4mg

Menthol Syrup Codeine Phosphate IP 10mg

Menthol IP 0.1mg

flavoured syrupy base q.s.

Colour: Carmoisine & Sunset Yellow FCF

305 Divalproex Sodium Extended Each film coated extended release

Release Tablets tablet contains:

Divalproex Sodium

Eq. to Valproic Acid 750mg

Excipients q.s.

colour: Iron Oxide Yellow

304 Divalproex Sodium Extended Each film coated extended release

Release Tablets tablet contains:

Divalproex Sodium

Eq. to Valproic Acid 1000mg

Excipients q.s.

colour: Iron Oxide Yellow

303 Olanzapine Mouth Dissolving Each uncoated mouth dissolving tablets tablet contains:

Olanzapine IP 15mg

Excipients q.s.

Page 90 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

302 Olanzapine Mouth Dissolving Each uncoated mouth dissolving tablets tablet contains:

Olanzapine IP 20mg

Excipients q.s.

301 Quetiapine Fumarate Sustained Each film coated sustained release

Release Tablets tablet contains:

Quetiapine Fumarate

Eq. to Quitiapine 100mg

Excipients q.s.

colour: Titanium Dioxide IP

300 Quetiapine Fumarate Sustained Each film coated sustained release

Release Tablets tablet contains:

Quetiapine Fumarate

Eq. to Quitiapine 200mg

Excipients q.s.

colour: Titanium Dioxide IP

299 Quetiapine Fumarate Sustained Each film coated sustained release

Release Tablets tablet contains:

Quetiapine Fumarate

Eq. to Quitiapine 300mg

Excipients q.s.

colour: Titanium Dioxide IP

298 Ivermectin & Albendazole Each uncoated dispersible tablet contains:

Dispersible Tablets Ivermectin BP 3mg

Albendazole IP 200mg

297 Ivermectin & Albendazole Tabs Each uncoated tablet contains:

Ivermectin BP 6mg

Albendazole IP 400mg

Colour: Lake of Quinoline yellow

296 Ivermectin & Albendazole Tabs Each uncoated tablet contains:

Ivermectin BP 12mg

Albendazole IP 400mg

Colour: Tartrazine

295 Glibenclamide & Metformin Each uncoated tablet contains:

Hydrochloride Tablets Glibenclamide IP 5mg

Metformin Hydrochloride IP 500mg

294 Glibenclamide & Metformin Each uncoated bilayered tablet contains:

Hydrochloride ER Tablets Glibenclamide IP 5mg

Metformin Hydrochloride IP 500mg

(in extended release form)

Colour: Brilliant blue Page 91 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

293 Glibenclamide,Pioglitazone & Each uncoated bilayered tablet contains:

Metformin HCl (ER) Tablets Glibenclamide IP 5mg

Pioglitazone Hydrochloride

Eq. to Pioglitazone 15mg

Metformin Hydrochloride IP 500mg

(in extended release form)

Colour: Erythrosine

292 Ofloxacin & Ornidazole Susp. Each 5ml contains:

Ofloxacin IP 50mg

Ornidazole 125mg

Colour: Tartrazine

291 Topiramate Tablets 25mg Each film coated tablet contains:

Topiramate USP 25mg

Excipients q.s.

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

290 Topiramate Tablets 50mg Each film coated tablet contains:

Topiramate USP 50mg

Excipients q.s.

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

289 Topiramate Tablets 100mg Each film coated tablet contains:

Topiramate USP 100mg

Excipients q.s.

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

288 Povidone-Iodine Vaginal Each pessary contains:

Pessaries Povidone-Iodine IP 20mg

(available Iodine 20mg)

287 Escitalopram Oxalate & Each film coated tablet contains:

Clonazepam Tablets Escitalopram Oxalate

Eq. to Escitalopram 10mg

Clonazepam IP 0.5mg

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

286 Escitalopram Oxalate & Each film coated tablet contains:

Clonazepam Tablets Escitalopram Oxalate

Eq. to Escitalopram 10mg

Clonazepam IP 0.5mg

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP Page 92 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

285 Levocarnitine Tablets USP 330mg Each film coated tablet contains:

Levocarnitine USP 330mg

Excipients q.s.

Colour: Titanium Dioxide IP

284 Levocarnitine Tablets USP 500mg Each film coated tablet contains:

Levocarnitine USP 500mg

Excipients q.s.

Colour: Titanium Dioxide IP

283 Calcium Acetate USP 667mg Each uncoated tablet contains:

Calcium Acetate USP 667mg

Flavoured excipients q.s

colour: Sunset yellow FCF

282 Diclofenac sodium & Each hard gelatin capsule contains:

Pantoprazole Capsules Diclofenac Sodium IP 75mg

(as sustained release pellets)

Colour: Titanium Dioxide IP

Pantoprazole Sodium Sesquihydrate

Eq. to Pantoprazole 40mg

(as enteric coated pellets)

Colour: Tartrazine

Approved colours used in capsule shell.

281 Metformin ER Tablets Each uncoated extended release tablet contains:

Metformin Hydrochloride IP 500mg

280 Prochlorperazine Dispersible Each uncoated dispersible tablet contains: tablets Prochlorperazine Maleate IP 5mg

279 Duloxetine Tablets Each enteric coated tablet contains:-

Duloxetine Hydrochloride

Eq. to Duloxetine 20mg

Excipients q.s.

Colour: Iron Oxide of Yellow

278 Duloxetine Tablets Each enteric coated tablet contains:-

Duloxetine Hydrochloride

Eq. to Duloxetine 30mg

Excipients q.s.

Colour: Iron Oxide of Red

277 Duloxetine Tablets Each enteric coated tablet contains:-

Duloxetine Hydrochloride

Eq. to Duloxetine 60mg

Excipients q.s.

Colour: Lake of Quinoline yellow Page 93 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

276 Divalproex Sodium Extended Each film coated extended release

Release Tablets tablet contains:

Divalproex Sodium

Eq. to Valproic Acid 250mg

Excipients q.s.

Colour: Iron Oxide of Yellow

275 Divalproex Sodium Extended Each film coated extended release

Release Tablets tablet contains:

Divalproex Sodium

Eq. to Valproic Acid 500mg

Excipients q.s.

Colour: Iron Oxide of Yellow

274 Clonazepam Mouth Dissolving Each uncoated mouth dissolving

Tablets 0.25mg tablet contains:

Clonazepam USP 0.25mg

Excipients q.s.

Colour: Ponceau 4R

273 Clonazepam Mouth Dissolving Each uncoated mouth dissolving

Tablets 0.5mg tablet contains:

Clonazepam USP 0.5mg

Excipients q.s.

Colour: Sunset Yellow FCF

272 Lorazepam Tablets BP 1mg Each uncoated tablet contains:

Lorazepam BP 1mg

Excipients q.s.

271 Lorazepam Tablets BP 2mg Each uncoated tablet contains:

Lorazepam BP 2mg

Excipients q.s.

270 Clonazepam Tablets USP 0.5mg Each uncoated tablet contains:

Clonazepam USP 0.5mg

Excipients q.s.

Colour: Tartrazine

269 Nitrazepam Tablets IP 10mg Each uncoated tablet contains:

Nitrazepam IP 10mg

Excipients q.s.

268 Nitrazepam Tablets IP 5mg Each uncoated tablet contains:

Nitrazepam IP 5mg

Excipients q.s.

267 Alprazolam Tablets IP 0.25mg Each uncoated tablet contains:

Alprazolam IP 0.25mg

Excipients q.s.

Page 94 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Erythrosine

266 Alprazolam Tablets IP 0.5mg Each uncoated tablet contains:

Alprazolam IP 0.5mg

Excipients q.s.

Colour: Sunset Yellow FCF

265 Trihexiphenidyl Hydrochloride Each uncoated tablet contains:

Tablets IP 2mg Trihexyphenidyl Hydrochloride IP 2mg

Excipients q.s.

264 Ofloxacin & Ornidazole Tablets Each film coated tablet contains:

Ofloxacin IP 200mg

Ornidazole 500mg

Colour: Titanium Dioxide IP

263 Drotaverine Hydrochloride & Each uncoated tablet contains:

Mefenamic Acid Tablets Drotaverine Hydrochloride 80mg

Mefenamic Acid IP 250mg

Colour: Lake of Quinoline Yellow

262 Lamivudine & Tenofovir Tablets Each film coated tablet contains:

Lamivudine IP 300mg

Tenofovir Disoproxil Fumarate IP 300mg colours: Yellow oxide of Iron & Titanium

Dioxide IP

261 Tranexamic Acid & Mefenamic Each film coated tablet contains:

Acid Tablets Tranexamic Acid BP 500mg

Mefenamic Acid IP 250mg

Colour: Quinoline yellow WS

260 Etamsylate & Mefenamic Acid Each uncoated tablet contains:

Tablets Etamsylate BP 250mg

Mefenamic Acid IP 250mg

259 Etamsylate & Mefenamic Acid Each uncoated tablet contains:

Tablets Etamsylate BP 500mg

Mefenamic Acid IP 500mg

258 Etamsylate & Tranexamic Tablets Each film coated tablet contains:

Etamsylate BP 250mg

Tranexamic Acid BP 250mg

Colour: Erythrosine

257 Etamsylate & Tranexamic Tablets Each film coated tablet contains:

Etamsylate BP 250mg

Tranexamic Acid BP 500mg

Colour: Erythrosine

256 Drotaverine Hydrochloride & Each uncoated tablet contains:

Mefenamic Acid Tablets Drotaverine Hydrochloride 80mg Page 95 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Mefenamic Acid IP 250mg colour: Lake of Quinoline yellow

255 Ofloxacin & Ornidazole Tablets Each film coated tablet contains:

Ofloxacin IP 200mg

Ornidazole 500mg

Colours: Tartrazine & Titanium Dioxide IP

254 S(-) Atenolol Tablets 12.5mg Each uncoated tablet contains:

S(-) Atenolol 12.5mg

253 S(-) Atenolol Tablets 25mg Each uncoated tablet contains:

S(-) Atenolol 25mg

252 S(-) Atenolol Tablets 50mg Each uncoated tablet contains:

251 Ofloxacin & Metronidazole Susp. Each 5ml contains:

S(-) Atenolol 50mg

Colour: Lake of Sunset yellow

Ofloxacin IP 50mg

Metronidazole Benzoate IP eq. to Metronidazole 100mg flavoured syrupy base q.s.

250 Ofloxacin & Metronidazole Susp. Each 5ml contains:

Colour: Quinoline yellow WS

Ofloxacin IP 100mg

Metronidazole Benzoate IP eq. to Metronidazole 200mg flavoured syrupy base q.s.

Colour: Quinoline yellow WS

249 S(-) Atenolol Tablets 12.5mg Each uncoated tablet contains:

S(-) Atenolol 12.5mg

248 S(-) Atenolol Tablets 25mg Each uncoated tablet contains:

S(-) Atenolol 25mg

247 S(-) Atenolol Tablets 50mg Each uncoated tablet contains:

S(-) Atenolol 50mg

Colour: Lake of Sunset yellow

246 Fluconazole Tablets 150mg Each uncoated tablet contains:

Fluconazole USP 150mg

Colour: Sunset yellow FCF

245 Fluconazole Tablets 200mg Each uncoated tablet contains:

Fluconazole USP 200mg

Colour: Sunset yellow FCF

244 Fluconazole Dispersible Tablets Each uncoated dispersible tablet contains:

50mg Fluconazole USP 50mg

243 Fluconazole Tablets 150mg Each uncoated tablet contains: Page 96 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Fluconazole USP 150mg

Colour: Sunset yellow FCF

242 Fluconazole Tablets 200mg Each uncoated tablet contains:

Fluconazole USP 200mg

Colour: Sunset yellow FCF

241 Fluconazole Dispersible Tablets Each uncoated dispersible tablet contains:

50mg Fluconazole USP 50mg

240 L-Carnitine L-Tartrate Tablets Each film coated tablet contains:

L-Carnitine L-Tartrate 725mg eq. to L-Carnitine 500mg

Colour: Titanium Dioxide IP

239 L-Carnitine L-Tartrate Tablets Each film coated tablet contains:

L-Carnitine L-Tartrate 478.5mg

eq. to L-Carnitine 330mg

Colour: Titanium Dioxide IP

238 Prebabalin Capsules 75mg Each hard gelatin capsule contains:

Pregabalin 75mg

Excipients q.s.

Approved colours used in capsule shell.

237 Prebabalin Capsules 150mg Each hard gelatin capsule contains:

Pregabalin 150mg

Excipients q.s.

Approved colours used in capsule shell.

236 Gabapentin Capsules 100mg Each hard gelatin capsule contains:

Gabapentin USP 100mg

Excipients q.s.

Approved colours used in capsule shell.

235 Gabapentin Capsules 300mg Each hard gelatin capsule contains:

Gabapentin USP 300mg

Excipients q.s.

Approved colours used in capsule shell.

234 Gabapentin Capsules 400mg Each hard gelatin capsule contains:

Gabapentin USP 400mg

Excipients q.s.

Approved colours used in capsule shell.

233 Nitazoxanide for Oral Suspension Each 5ml of reconstituted suspension contains:

Nitazoxanide 100mg

Excipients q.s.

Colour: Ponceau 4R

232 Ofloxacin & Nitazoxanide for Each 5ml of reconstituted suspension Page 97 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Oral Suspension contains:

Ofloxacin IP 50mg

Nitazoxanide 100mg

Excipients q.s.

Colour: Titanium Dioxide IP

231 L-Ornithine L-Aspartate Each film coated tablet contains:

Tablets 150mg L-Ornithine L-Asparate 150mg

Colour: Iron oxide Red &

Titanium Dioxide BP

230 Lornoxicam & Paracetamol Tabs Each film coated tablet contains:

Lornoxicam 8mg

Paracetamol IP 500mg

Colour: Quinoline yellow lake &

Titanium Dioxide IP

229 Lornoxicam & Paracetamol Tabs Each film coated tablet contains:

Lornoxicam 4mg

Paracetamol IP 500mg

Colour: Quinoline yellow lake &

Titanium Dioxide IP

228 Lamivudine & Tenofovir Tablets Each film coated tablet contains:

Lamivudine IP 300mg

Tenofovir Disoproxil Fumarate IP 300mg

Colour: Yellow Oxide of Iron &

227 Gliclazide Tablets BP Each uncoated tablet contains:

Titanium Dioxide IP

Gliclazide BP 80mg

226 Labetalol Tablets BP Each film coated tablet contains:

Labetalol Hydrochloride BP 100mg

Colour: Quinoline Yellow

225 Codeine Phosphate & Each 5ml contains:

Chlorpheniramine Maleate Syp. Codeine Phosphate IP 10mg

Chlorpheniramine Maleate IP 4mg

In a pleasantly flavoured syrupy base

Colour: Carmoisine & Sunset Yellow FCF

224 Ambroxol HCl, R-Salbutamol, Each 5ml contains:

Guaipenesin & Menthol Syrup Ambroxol Hydrochloride IP 15mg

R-Salbutamol (As sulphate) 1mg

Guaiphenesin IP 50mg

Menthol IP 1mg flavoured syrupy base q.s.

223 Ofloxacin & Ornidazole Susp. Each 5ml contains: Page 98 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Ofloxacin IP 50mg

Ornidazole 125mg

Excipients q.s.

In a flavoured syrupy base

Colour: Sunset Yellow FCF

222 Codeine Phosphate & Each ml contains:

Chlorpheniramine Maleate Syp. Codeine Phosphate IP 10mg

Chlorpheniramine Maleate IP 4mg flavoured syrupy base q.s.

Colour: Caramel IP

221 Glimepiride Tablets Each uncoated tablet contains:

Glimepiride USP 1mg

Excipients q.s.

220 Ofloxacin & Ornidazole Susp. Each 5ml contains:

Ofloxacin IP 50mg

Ornidazole 125mg

Excipients q.s.

In a Mango flavoured syrupy base

Colour: Sunset Yellow FCF

219 Metronidazole Benzoate Oral Each 5ml contains:

Suspension IP Metronidazole Benzoate IP

Eq. to Metronidazole 200mg

Colour: Quinoline yellow

218 Levofloxacin Tablets I.P Each film coated tablet contains:

Levofloxacin Hemihydrate eq. to Levofloxacin 250mg

Colour: Lake of sunset yellow FCF &

Titanium Dioxide I.P

217 Rabeprazole Sodium Tablets IP Each enteric coated tablet contains:-

Rabeprazole Sodium IP 20mg

Colour: Yellow Oxide of Iron &

Titanium Dioxide IP

216 Ondansetron HCl Dispersible Tab Each uncoated dispersible tablet contains:

Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

215 Ondansetron Oral Solution USP Each 5ml contains:

Ondansetron Hydrochloride USP

Eq. to Ondansetron 2mg

In a flavoured syrupy base

Colour: Ponceau 4R

214 Ondansetron Hydrochloride Each uncoated dispersible tablet contains: Page 99 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Dispersible Tablets Ondansetron Hydrochloride USP

Eq. to Ondansetron 4mg

Colour: Lake of Quinoline yellow

213 Ondansetron Hydrochloride Each uncoated dispersible tablet contains:

Dispersible Tablets Ondansetron Hydrochloride USP

Eq. to Ondansetron 8mg

211 Codeine Phosphate & Levocetiri- Each 5ml contains:

Colour: Titanium Dioxide IP zine Hydrochloride & Menthol Codeine Phosphate IP 10mg

Syrup Levocetirizine Hydrochloride IP 2.5mg

Menthol IP 0.1mg

flavoured syrupy base q.s.

Colour: Ponceau 4R

210 Acarbose Tablets IP Each uncoated tablet contains:

Acarbose IP 25mg

Excipients q.s.

209 Acarbose Tablets IP Each uncoated tablet contains:

Acarbose IP 50mg

Excipients q.s.

208 Levofloxacin Tablets I.P Each film coated tablet contains:

Levofloxacin Hemihydrate IP eq. to Levofloxacin 250mg

Excipients q.s.

Colour: Iron Oxide Red, Iron Oxide

Yellow & Titanium Dioxide IP

207 Levofloxacin Tablets I.P Each film coated tablet contains:

Levofloxacin Hemihydrate IP eq. to Levofloxacin 500mg

Excipients q.s.

Colour: Iron Oxide REd &

Titanium Dioxide IP

206 Tizanidine Tablets IP Each uncoated tablet contains:

Tizanidine Hydrochloride IP

Eq. to Tizanidine 2mg

Excipients q.s.

205 Acarbose Tablets IP Each uncoated tablet contains:

Acarbose IP 25mg

Excipients q.s.

204 Acarbose Tablets IP Each uncoated tablet contains:

Acarbose IP 50mg

Excipients q.s.

Page 100 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

203 Ofloxacin Tablets IP Each film coated tablet contains:

Ofloxacin IP 200mg

Excipients q.s.

Colour: Titanium Dioxide IP

202 Hyoscine Butylbromide & Each film coated tablet contains:

Paracetamol Tablets Hyoscine Butylbromide IP 10mg

Paracetamol IP 500mg

Colour: Titanium Dioxide IP

201 Levocetirizine Hydrochloride, Each 5ml contains:

Dextromethorphan HBr & Levocetirizine Hydrochloride IP 2.5mg

Guaipenesin, Ammonium Dextromethorphan HBr IP 5mg chloride & Menthol Syrup Guaiphenesin IP 50mg

Ammonium Chloride IP 60mg

Menthol IP 1mg

Colour: Ponceau 4R & Carmoisine

200 Pregabalin Capsules 50mg Each hard gelatin capsule contains:

Pregabalin 50mg

Excipients q.s.

Approved colours used in capsule shell.

199 Enter Coated Rabeprazole Sodium Each hard gelatin capsule contains:

& Domperidone Capsules Rabeprazole Sodium 20mg

(as enteric coated pellets)

Domperidone BP 30mg

(10mg as immediate release and 20mg as sustained release pellets)

Colours: Iron Oxide Red, Iron Oxide Yellow

& Titanium Dioxide IP

Approved colours used in capsule shell.

198 Domperidone & Pantoprazole Each hard gelatin capsule contains:

SR Capsules Domperidone Maleate IP

Eq. to Domperidone 10mg

(Immediate release)

Domperidone Maleate IP

Eq. to Domperidone 20mg

(as sustained release tablet)

Colour: Red Oxide of Iron

Pantoprazole Sodium Sesquihydrate

Eq. to Pantoprazole 40mg

(as two enteric coated tablets)

Colour: Tartrazine yellow

Excipients q.s.

Page 101 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Approved colours used in capsule shell.

197 Rabeprazole & Domperidone Each hard gelatin capsule contains:

SR Capsules Rabeprazole Sodium IP 20mg

(as enteric coated tablet)

Colour: Yellow Oxide of Iron

Domperidone Maleate IP

Eq. to Domperidone 10mg

(Immediate release)

Domperidone Maleate IP

Eq. to Domperidone 20mg

(as sustained release tablet)

Colour: Red Oxide of Iron

Excipients q.s.

Approved colours used in capsule shell.

196 Ivermectin Dispersible Tabs 6mg Each uncoated dispersible tablet contains:

Ivermectin IP 6mg

Colour: Lake of Tartrazine

195 Ivermectin Dispersible Tabs 3mg Each uncoated dispersible tablet contains:

Ivermectin IP 3mg

194 Ivermectin Tablets 12mg Each uncoated tablet contains:

Ivermectin IP 12mg

193 Levocetirizine Tablets IP Each film coated tablet contains:

Levocetirizine Hydrochloride IP 5mg

Excipients: q.s

Colour: Titanium Dioxide IP

192 L-Ornithine L-Aspartate Granules Each 5g sachet contains:

L-Ornithine L-Aspartate 3g

Flavoured base

Colour: Sunset yellow FCF

191 Levocetirizine Tablets IP Each film coated tablet contains:

Levocetirizine Hydrochloride IP 5mg

Colour: Titanium Dioxide IP

190 Sucralfate & Oxetacaine Susp. Each 10ml contains:

Sucralfate USP 1gm

Oxetacaine BP 20mg

Flavoured base q.s.

Colour: Quinolline Yellow WS

189 Ivermectin Dispersible Tabs 6mg Each uncoated dispersible tablet contains:

Ivermectin BP 6mg

Colour: Lake of Tartrazine

Page 102 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

188 Mefenamic Acid & Paracetamol Each uncoated tablet contains:-

Tablets Mefenamic Acid IP 500mg

Paracetamol IP 450mg

Colour: Tartrazine

187 Lornoxicam & Paracetamol Tablets Each filmcoated tablet contains:

Lornoxicam 8mg

Paracetamol IP 500mg

Colour: Quinoline yellow Lake &

Titanium Dioxide IP

186 Orlistat Capsules 60mg Each hard gelatin capsule contains:

Orlistat 60mg

(As pellets 50% w/w)

Approved colours used in capsule shell.

185 Orlistat Capsules 120mg Each hard gelatin capsule contains:

Orlistat 120mg

(As pellets 50% w/w)

Approved colours used in capsule shell.

184 Codeine Phosphate, Levocetirizine Each 5ml contains:

Hydrochloride & Menthol Syrup Codeine Phosphate IP 10mg

Levocetirizine Hydrochloride IP 1.67mg

Menthol IP 0.1mg

flavoured syrupy base q.s

Colour: Ponceau 4R

183 Aceclofenac, Paracetamol & Each filmcoated tablet contains:

Chlorzoxazone Tablets Aceclofenac IP 100mg

Paracetamol IP 500mg

Chlorzoxazone USP 500mcg

Excipients: q.s.

Colour: Lake of Sunset yellow FCF

182 Finasteride Tablets USP 5mg Each film coated tablet contains:

Finasteride USP 5mg

Colour: Titanium dioxide IP &

Indigocarmine

181 Sertraline & Alprazolam SR Tablets Each uncoated bilayered tablet contains:

Sertraline Hydrochloride eq. to Sertraline 25mg

Alprazolam IP 0.5mg

(In sustained release form)

Colour: Tartrazine yellow

180 Sertraline & Alprazolam SR Tablets Each uncoated bilayered tablet contains:

Sertraline Hydrochloride Page 103 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Sertraline 50mg

Alprazolam IP 0.5mg

(In sustained release form)

Colour: Tartrazine yellow

179 Glibenclamide, Rosiglitazone & Each uncoated bilayered tablet contains:

Metformin HCl (ER) Tablets Glibenclamide IP 5mg

Rosiglitazone Maleate IP eq. to Rosiglitazone 2mg

Metformin Hydrochloride IP 500mg

(In extended release form) colour: Iron oxide of Red

178 Nimesulide & Paracetamol Tablets Each uncoated tablet contains:-

Nimesulide BP 100mg

Paracetamol IP 500mg

Colour: Tartrazine

177 Nimesulide & Paracetamol Susp. Each 5ml contains:

Nimesulide I.P 50mg

Ornidazole 125mg

Excipients q.s.

colour: Quinoline yellow FCF

176 Ofloxacin & Ornidazole Suspension Each 5ml contains:

Ofloxacin IP 50mg

Ornidazole 125mg colour: Quinoline yellow FCF

175 Esomeprazole Tablets 40mg Each film coated tablet contains:

Esomeprazole Magnesium Trihydrate

Eq. to Esomeprazole 40mg

Colour: Red Oxide Iron & Titanium Dioxide BP

174 Esomeprazole Tablets 20mg Each film coated tablet contains:

Esomeprazole Magnesium Trihydrate

Eq. to Esomeprazole 20mg

Colour: Red Oxide Iron & Titanium Dioxide BP

173 Ambroxol Hydrochloride, Terbuta- Each ml contains: line Sulphate & Guaiphenesin Syrup Ambroxol Hydrochloride IP 7.5mg

Terbutaline sulphate IP 0.25mg

Guaiphenesin IP 12.5mg

flavoured syrupy base q.s

Colour: Tartrazine

172 Levocetirizine Hydrochloride, Each film coated tablet contains:

Phenylephrine Hydrochloride, Levocetirizine Hydrochloride IP 5mg

Ambroxol Hydrochloride Tablets Phenylephrine Hydrochloride IP 5mg Page 104 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Ambroxol Hydrochloride IP 60mg

Colour: Titanium Dioxide IP

171 Desloratadine, Phenylephrine HCl, Each film coated tablet contains:

Amboroxol Hydrochloride Tablets Desloratadine 5mg

Phenylephrine Hydrochloride IP 5mg

Ambroxol Hydrochloride IP 60mg

Colour: Red Oxide Iron & Titanium Dioxide IP

170 Lornoxicam & Paracetamol Tablets Each film coated tablet contains:

Lornoxicam 8mg

Paracetamol IP 500mg

Colour: Quinoline yellow Lake &

Titanium Dioxide IP

169 Lornoxicam & Paracetamol Tablets Each film coated tablet contains:

Lornoxicam 4mg

Paracetamol IP 500mg

Colour: Quinoline yellow Lake &

Titanium Dioxide IP

168 Amlodipine Tablets IP Each uncoated tablet contains:-

Amlodipine Besylate IP

Eq. to Amlodipine 2.5mg

167 Amlodipine & Lisinopril Tablets Each uncoated tablet contains:-

Amlodipine Besylate IP

Eq. to Amlodipine 5mg

Lisinopril IP (as Dihydrate) 5mg

166 AtorvastatinTablets I.P. 10mg Each film coated tablet contains:

Atorvastatin Calcium I.P

eq. to Atorvastatin 10mg

Excipients q.s.

Colour: Black Oxide of Iron &

Titanium Dioxide IP

165 Propranolol Tablets BP Each uncoated tablet contains:-

Propranolol Hydrochloride BP 40mg

164 Carbamazepine Tablets BP Each uncoated tablet contains:-

Carbamazepine BP 200mg

163 Diazepam Tablets BP Each uncoated tablet contains:-

Diazepam BP 5mg

162 Lornoxicam Tablets 4mg Each filmcoated tablet contains:

Lornoxicam 4mg

Colour: Quinolline Yellow (Lake) &

Titanium Dioxide BP

161 Lornoxicam Tablets 8mg Each filmcoated tablet contains: Page 105 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Lornoxicam 8mg

Colour: Quinolline Yellow (Lake) &

Titanium Dioxide BP

160 Diclofenac Dispersible Tablets Each dispersible tablet contains:

46.5mg of Diclofenac Free Acid eq. to Diclofenac Sodium IP 50mg

159 Acarbose Tablets IP Each filmcoated tablet contains: colour: Tartrazine

Acarbose IP 25mg

Excipients: q.s.

158 Acarbose Tablets IP Each filmcoated tablet contains:

Colour: Titanium Dioxide IP

Acarbose IP 50mg

Excipients: q.s.

Colour: Titanium Dioxide IP

157 Atorvastatin & Ezetimibe Tablets Each filmcoated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 10mg

Ezetimibe 10mg

Excipients: q.s.

Colours: Iron Oxide Red, Iron oxide yellow &

Titanium Dioxide IP

156 Clopidogrel Tablets USP Each filmcoated tablet contains:

Clopidogrel Bisulfate USP eq. to Clopidogrel 75mg

Colours: Iron Oxide Red & Titanim Dioxide IP

154 Mecobalamin Tablets Each filmcoated tablet contains:

Mecobalamin 500mcg

Colours: Erythrosine & Titanium Dioxide IP

153 Atorvastatin & Ezetimibe Tablets Each filmcoated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 10mg

Ezetimibe 10mg colours: Sunset yellow lake & Tio2 IP

152 Ondansetron HCl Dispersible Each uncoated dispersible tablet contains:-

Tablets 2mg Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

151 Ondansetron HCl Dispersible Each uncoated dispersible tablet contains:-

Tablets 4mg Ondansetron Hydrochloride USP eq. to Ondansetron 4mg

Page 106 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Colour: Quinolline Yellow

150 Ondansetron HCl Dispersible Each uncoated dispersible tablet contains:-

Tablets 8mg Ondansetron Hydrochloride USP eq. to Ondansetron 8mg

Colour: Sunset yellow FCF

149 Clonazepam Dispersible Each uncoated dispersible tablet contains:-

Tablets 1mg Clonazepam IP 1mg

Colour: Sunset yellow FCF

148 Telmisartan & Hydrochlorthiazide Each uncoated tablet contains:-

Tablets Telmisartan 40mg

Hydrochlorothiazide IP 12.5mg

Excipients: q.s

147 Telmisartan Tablets Each uncoated tablet contains:-

Telmisartan 40mg

Excipients: q.s

146 Telmisartan Tablets Each uncoated tablet contains:-

Telmisartan 20mg

Excipients: q.s

145 Telmisartan Tablets 40mg Each film coated tablet contains:

Telmisartan 40mg

Excipients: q.s

Colour: Titanium Dioxide BP

144 Telmisartan Tablets 80mg Each filmcoated tablet contains:

Telmisartan 80mg

Excipients: q.s.

colour: Titanium Dioxide BP

143 Doxofylline Tablets 400mg Each uncoated tablet contains:-

Doxofylline 400mg

Excipients: q.s

142 Controlled Release Tablets of Each filmcoated controlled release

Trimetazidine Hydrochloride tablet contains:

Trimetazidine Hydrochloride BP 35mg

Excipients: q.s

Colour: Yellow Oxide of Iron & Titanium

Dioxide B.P

141 Oxcarbazepine Tablets 150mg Each filmcoated tablet contains:

Oxcarbazepine 150mg

Excipients: q.s

Colour: Yellow Oxide of Iron

140 Aceclofenac Sustained Each filmcoated sustained release

Page 107 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Release tablets 200mg tablet contains:

Aceclofenac BP 200mg

Excipients: q.s

Colour: Titanium Dioxide BP

139 Aceclofenac 100mg & Paracetamol Each filmcoated tablet contains:

650mg Tablets Aceclofenac BP 100mg

Paracetamol BP 650mg

Excipients: qs.

Colour: Quinoline yellow

138 Metformin Sustained Each uncoated sustained release

Release Tablets 1gm tablet contains:

Metformin Hydrochloride BP 1.0gm

Excipients: q.s.

137 Diacerein Capsules 50mg Each hard gelatin capsule contains:

Diacerein 50mg

Excipients: q.s

Approved colours used in capsule shell.

136 Sibutramine Hydrochloride Each hard gelatin capsule contains:

Monohydrate Capsule 10mg Sibutramine HCl Monohydrate 10mg

Excipients: q.s

Approved colours used in capsule shell.

135 Amlodipine Besylate Tablets Each uncoated tablet contains:-

Amlodipine Besylate BP eq. to Amlodipine 5mg

Colour: Iron Oxide Red

134 Aspirin Tablets BP Each uncoated tablet contains:-

Aspirin BP 300mg

133 Co-Trimoxazol Tablets BP Each uncoated tablet contains:-

Trimethoprim BP 160mg

Sulfamethoxazole BP 800mg

132 Metformin tablets BP Each filmcoated tablet contains:

Metformin Hydrochloride BP 500mg

Colour: Titanium Dioxide BP

131 Ibuprofen Tablets BP 400mg Each filmcoated tablet contains:

Ibuprofen BP 400mg

Colour: Erythrosine (Lake)

130 Ibuprofen Tablets BP 600mg Each filmcoated tablet contains:

Ibuprofen BP 600mg

Colour: Erythrosine (Lake)

129 Clopidogrel Tablets USP 75mg Each filmcoated tablet contains:

Clopidogrel Bisulfate USP Page 108 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Clopidogrel 75mg

Colour: Titanium Dioxide BP &

Red Oxide of Iron

128 AtorvastatinTablets 10mg Each film coated tablet contains:

Atorvastatin Calcium eq. to Atorvastatin 10mg

Colour: Titanium Dioxide B.P

127 Loratadine Tablets USP 10mg Each uncoated tablet contains:-

Loratadine USP 10mg

126 Diclofenac Sodium & Each hard gelatin capsule contains:

Pantoprazole Capsules Diclofenac sodium IP 75mg

(as sustained release pellets)

Colour: Titanium Dioxide IP

Pantoprazole Sodium Sesquihydrate

Eq. to Pantoprazole 40mg

(as enteric coated pellets)

Colour: Tartrazine

Approved colours used in capsule shell.

125 Ivermectin Dispersible Tabs 6mg Each uncoated dispersible tablet contains:-

Ivermectin I.P 6mg

Colour: Lake of Tartrazine

124 Ivermectin Dispersible Tabs 3mg Each uncoated dispersible tablet contains:-

Ivermectin I.P 3mg

123 Ivermectin Tablets 12mg Each uncoated tablet contains:-

Ivermectin I.P 12mg

122 Orlistat Capsules 120mg Each hard gelatin capsule contains:

Orlistat 120mg

Excipients q.s.

Approved colours used in capsule shell.

121 Orlistat Capsules 60mg Each hard gelatin capsule contains:

Orlistat 60mg

Excipients q.s.

Approved colours used in capsule shell.

120 Amlodipine Tablets IP Each uncoated tablet contains:-

Amlodipine Besylate IP

Equivalent to Amlodipine 10mg

119 Amlodipine Tablets IP Each uncoated tablet contains:-

Amlodipine Besylate IP

Equivalent to Amlodipine 5mg

118 Lomefloxacin Tablets 400mg Each film coated tablet contains:

Lomefloxacin Hydrochloride Page 109 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Equivalent to Lomefloxacin 400mg

Colour: Titanium Dioxide BP

117 Losartan Potassium Tablets 25mg Each film coated tablet contains:

Losartan Potassium USP 25mg

Colour: Red Oxide of Iron &

Titanium Dioxide B.P

116 Losartan Potassium Tablets 50mg Each film coated tablet contains:

Losartan Potassium USP 50mg

Colour: Titanium Dioxide B.P

115 Ondansetron Tablets 4mg Each film coated tablet contains:

Ondansetron Hydrochloride USP

Equivalent to Ondansetron 4mg

Colour: Titanium Dioxide B.P

114 Ondansetron Oral Solution USP Each 5ml contains:

Ondansetron Hydrochloride USP

Equivalent to Ondansetron 2mg

Colour: Ponceau 4R

113 Levocetirizine Tablets IP Each film coated tablet contains:

Levocetirizine Hydrochloride IP 5mg

Excipients q.s.

Colour: Ponceau 4R

112 Serratiopeptidase & Diclofenac Each enteric film coated tablet contains: DCG (I) +

Potassium Tablets Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units)

Diclofenac Potassium BP 50mg

Colours: Sunset yellow (Lake) & Erythrosine

111 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) +

Acid, Vit. B6 & Folic Acid Caps Mecobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine HCl IP 3mg

Folic Acid IP 1.5mg

Appropriate overages of vitamins added to compensate loss on storage.

110 Methylcobalamin, Vitamin B6 & Each 2ml contains:

Approved colours used in capsule shell.

Nicotinamide Injection Methylcobalamin 1000mcg

Pyridoxine HCl IP 100mg

Nicotinamide IP 100mg

Benzyl Alcohol IP 2% w/v

(as preservative)

Page 110 of 252

DCG (I) +

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Water for Injection IP q.s

109 Multivitamin & Minerals Drops Each ml contains:

Vitamin D3 IP 200IU

Pyridoxine Hydrochloride IP 0.6mg

Niacinamide IP 5mg

D-Panthenol IP 1.5mg

Cyanocobalamin IP 1mcg

Folic Acid IP 50mcg

Ferric Ammonium Citrate IP eq. to elemental Iron 2mg

Copper Gluconate USP eq. to elemental Copper 100mcg

Magnesium Sulphate IP eq. to elemental Magnesium 5mg

Zinc Gluconate USP eq. to elemental Zinc 1mg flavoured base q.s.

108 Mecobalamin & Vitanins Inj. Each 3ml contains:

Mecobalamin 1000mcg

Thiamine Hydrochloride IP 100mg

Pyridoxine Hydrochloride IP 100mg

D-Panthenol IP 50mg

Nicotinamide IP 100mg

Riboflavin Sod. Phosphate IP 5mg

Benzyl Alcohol IP 2% w/v

(as preservative)

Phenol IP 0.5% w/v

(as preservative)

Water for Injection IP q.s

107 Tramadol Injection 50mg Each ml contains:

Tramadol Hydrochloride BP 50mg

Water for Injection IP q.s

106 Tramadol Injection 100mg Each ml contains:

Tramadol Hydrochloride BP 100mg

Water for Injection IP q.s

105 L-Ornithine L-Aspartate Infusion Each 10ml contains:

L-Ornithine L-Aspartate 5g

Water for Injection IP q.s

104 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 500mg

Water for Injection IP q.s

Page 111 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

103 Methylcobalamin Injection Each ml contains:

Methylcobalamin 500mcg

Benzyl Alcohol IP. 85 2% w/v

(as preservative)

Water for Injection IP q.s

102 Tranexamic Acid Injection B.P Each 5ml contains:

101 L-Ornithine L-Aspartate Infusion Each 10ml contains:

L-Ornithine L-Aspartate 5g

Water for Injection IP q.s.

100 Ondansetron Injection USP Each ml contains:

Tranexamic Acid BP 500mg

Water for Injection IP q.s.

Ondansetron Hydrochloride USP eq. to Ondansetron 2mg

Water for Injection IP q.s.

99 Ondansetron, Ranitidine Injection A Pack (2ml)

Each ml contains:

Ondansetron Hydrochloride USP

As dihydrate eq. to Ondansetron 2mg

Water for Injection IP q.s.

B Pack (2ml)

Each ml contains:

Ranitidine Hydrochloride IP eq. to Ranitidine 25mg

Water for Injection IP q.s

98 Tetracycline Capsules IP Each capsule contains:

Tetracycline Hydrochloride IP 250mg

Approved colour used in capsule shells

97 Doxycycline Capsules IP Each capsule contains:

Doxycycline Hyclate IP eq. to doxycycline 100mg

96 Iron with Vitanins Caps Each hard gelatin capsule contains:

Carbonyl Iron eq. to elemental Iron 100mg

Folic Acid IP 1.5mg

Vitamin B12 IP 15mcg

Zinc Sulphate Monohydrate USP 61.8mg

95 Lincomycin with Lactic Acid Each hard gelatin capsule contains:

Bacillus Capsules Lincomycin Hydrochloride IP eq. to Lincomycin 250mg

Lactic Acid Bacillus 40 million spores Page 112 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Approved colours used in capsule shell.

94 Lincomycin with Lactic Acid Each hard gelatin capsule contains:

Bacillus Capsules Lincomycin Hydrochloride IP eq. to Lincomycin 500mg

Lactic Acid Bacillus 60 million spores

Approved colours used in capsule shell.

93 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: folic Acid, Vitanin B6 Caps Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride IP 3mg

Folic Acid IP 1.5mg

(containing Methylcobalamin & Folic Acid as film coated tablets)

Colour: Titanium Dioxide IP & Iron Oxide Red

Appropricate overages of vitamins are added.

92 Lincomycin Injection 300mg Each ml contains:

Lincomycin Hydrochloride IP eq. to Lincomycin 300mg

Benzyl Alcohol IP 9mg

(as preservative)

91 Lincomycin Injection 600mg Each 2ml contains:

Lincomycin Hydrochloride IP eq. to Lincomycin 600mg

Benzyl Alcohol IP 18mg

(as preservative)

90 Tramadol Injection 50mg Each ml contains:

Tramadol Hydrochloride BP 50mg

89 Tramadol Injection 100mg Each ml contains:

Tramadol Hydrochloride BP 100mg

88 Etamsylate Injection Each 2ml contains:

Etamsylate BP 250mg

87 Diclofenac Injection Each ml contains:

Diclofenac Sodium IP 25mg

86 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 500mg

Water for Injection IP q.s.

85 Ranitidine HCl Injection IP Each 2ml contains:

Ranitidine Hydrochloride IP eq. to Ranitidine 50mg

84 Methylcobalamin Injection Each ml contains:

Methylcobalamin 500mcg Page 113 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Benzyl Alcohol IP'85 2% w/v

(as preservative)

Water for Injection IP q.s.

83 L-Ornithine L-Aspartate Infusion Each 10ml contains:

Concentrate L-Ornithine L-Aspartate 5g

82 Mulivitamin with Minerals syrup Each 5ml contains:

Water for Injection IP q.s

Vitamin A (Palmitate) IP IU

Vitamin D3 IP 200IU

Thiamine Hydrochloride IP 2mg

Riboflavine Sodium Phosphate IP 1.5mg

Nicotinamide IP 25mg

D-Panthenol IP 2.5mg

Pyridoxine Hydrochloride IP 1mg

Vitamin C IP 30mg

Vitamin B12 IP 1mcg

(as anhydrous)

Calcium Gluconate IP 13mg

Calcium Lactose IP 13mg

Calcium Hypophosphite 100mg

Magnesium Hypophosphite 2.5mg

Ferrous Gluconate IP 6.5mg

Lysine Hydrochloride USP 75mg

Sorbitol Solution 70% IP q.s.

In a non syrupy base

Total available calcium 26.38mg/5ml

Overages of vitamins added to compensate for loss on storage.

81 Mulivitamin with Minerals syrup Each ml contains:

Vitamin A IP 2500IU

(as Vitamin A Palmitate)

Vitamin E Acetate IP 5IU

Cholecalciferol IP 200IU

Biotin IP 30mcg

Thiamine Hydrochloride IP 1mg

Riboflavine Sodium Phosphate IP 1mg

Pyridoxine Hydrochloride IP 1mg

Niacinamide IP 15mg

Cyanocobalamin IP 1mcg

D-Panthenol IP 2.5mg

Zinc Sulphate IP Page 114 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS eq. to Zinc 3mg

Manganese Chloride USP eq. to Manganese 0.8mg

Sodium Molybdate Dihydrate BP eq. to Molybdenum 8mcg

Sodium Selenate eq. to Selenium 10mcg

Potassium Iodide IP 50mcg

Lysine Hydrochloride BP 30mg

In a flavoured syrypy base

Colour: Quinoline yellow

Appropriate overages of vitamins added.

80 Iron with Vitanins Caps Each hard gelatin capsule contains:

Carbonyl Iron eq. to elemental Iron 100mg

Folic Acid IP 1.5mg

Cyanocobalamin IP 5mcg

Vitamin E IP 15IU

Vitamin C IP 75mg

Sodium selenate eq. to selenate 60mcg

Zinc Sulphate Monohydrate USP 61.8mg

eq. to elemental Zinc 22.5mg

Approved colours used in capsule shell.

79 Lincomycin HCl Capsules IP Each capsule contains:

Lincomycin Hydrochloride IP eq. to Lincomycin base 500mcg

Approved colours used in capsule shell.

78 Mecobalamin, Alpha Lipoic Acid, Each hard gelatin capsule contains: folic Acid & Vitamin B6 Caps Mecobalamin 500mcg

Alpha Lipoic Acid USP 100mg

Folic Acid IP 1.5mg

Pyridoxine Hydrochloride IP 3mg

(containing Methylcobalamin & Folic Acid as film coated tablets)

Colour: Sunset yellow

Appropriate overages of vitamin added to compensate for loss on storage.

Approved colours used in capsule shell.

77 Multivitamin & Minerals Caps Each hard gelatin capsule contains:

ß-Carotene 2.4mg

as 20% powder) Page 115 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Niacinamide IP 26mg

Vitamin C IP 50mg

Folic Acid IP 300mcg

Calcium Pantothenate IP 5mg

Vitamin E Acetate IP 10IU

Cyanocobalamin IP 1mcg

Biotin IP 30mcg

Vitamin A concentratem(as Acetate) IP 2500IU

Vitamin D3 IP 200IU

Vitamin B6 IP 1.5mg

Thiamine Mononitrate IP 2mg

Vitamin B2 IP 3mg

Copper Sulphate Pentahydrate BP 8mg

Manganese Sulphate Monohydrate BP 2.8mg

Zinc Sulphate IP 2.2mg

Selenium (as Selenium Dioxide) 60mcg

Iodine (as Potassium Iodide IP) 150mcg

Molybedenum

(as sodium molybdate dihydrate) 25mcg

Nickel (as Nickel Sulphate) 5mcg

Tin (as stannous chloride dihydrate BP) 10mcg

Silicon (as colloidal Silicon Dioxide IP) 2mg

Vanadium (as sodium Metavanadate) 10mcg

Boron (as Sodium Borate USP) 150mcg

Chromium Polynicotinate 400mcg eq. to Chromium 50mcg

Excipients q.s.

Approved colours used in capsule shell.

Overages of vitamins added to compensate loss on storage.

76 Gabapentin & Mecobalamin Tabs Each film coated tablet contains:

Gabapentin USP 300mg

Mecobalamin 500mcg

Colour: Ponceau 4R & Titanium Dioxide IP

75 Methylcobalamin Tabs Each uncoated sublingual tablet contains:

Methylcobalamin 1500mcg

(for Sublingual use)

74 Gabapentin & Methylcobalamin Tabs Each film coated tablet contains:

Gabapentin USP 300mg

Methylcobalamin 500mcg

Colour: Ponceau 4R & Titanium Dioxide IP Page 116 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

73 Ascorbic Acid, Zinc & Each film coated tablet contains:

Selenium Tablets Ascorbic Acid IP 500mg

(as sustained release)

Zinc (as zinc citrate anhydrous) 2.2mg

Selenium (as selenomethionine) 60mcg

Colour: Lake sunset yellow FCF &

Titanium Dioxdie IP

72 Diclofenac Potassium & Each enteric-film coated tablet contains:

Serratiopeptidase Tablets Diclofenac Sodium BP 50mg

Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units)

Colour: Sunset yellow lake & Erythrosine

71 Biotin Tablets Each film coated tablet contains:

Biotin BP 5mcg

Excipients q.s.

Colour: Titanium Dioxide IP

70 Serratiopeptidase & Diclofenac Each enteric-film coated tablet contains:

Potassium Tablets Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units)

Diclofenac Sodium BP 50mg

Colour: Titanium Dioxide IP & Sunset yellow FCF

69 Methylcobalamin & Gabapentin Tabs Each film coated tablet contains:

Gabapentin USP 300mg

Methylcobalamin 500mcg

Appropriate overages of vitamin is added.

Colour: Ponceau 4R

68 Serratiopeptidase Tablets Each enteric coated tablet contains:

Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units)

Colour: Titanium Dioxide IP & Erythrosine

67 Calcium Citrate & Vit. D3 Tabs Each uncoated tablet contains:

Calcium Citrate USP 1000mg

Vitamin D3 IP 200IU

66 Biotin Tablets 5mg Each film coated tablet contains:

Biotin BP 5mg

Excipients q.s.

Colour: Titanium Dioxide IP

65 Roxithromycin & Ambroxol Each film coated tablet contains:

Hydrochloride Tablets Roxithromycin BP 150mg

Ambroxol Hydrochloride BP 60mg

Colour: Sunset yellow & Titanium Dioxide IP Page 117 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

64 Roxithromycin Dispersible Each uncoated dispersible tablet contains:

Tablets 75mg Roxithromycin BP 75mg

Colour: Sunset yellow supra

63 Roxithromycin Tablets Each film coated tablet contains:

Roxithromycin BP 150mg

Colour: Titanium Dioxide IP

62 Methylcobalamin & Gabapentin Tabs Each film coated tablet contains:

Gabapentin USP 300mg

Methylcobalamin JP 500mcg

Appropriate overages of vitamin is added.

Colour: Ponceau 4R

61 Calcium Carbonate & Vit. D3 Tab Each film coated tablet contains:

1.25gm of Calclium Carbonate from an organic source (Oyster shell) eq. to elemental calcium 500mcg

Cholecalciferol IP 250IU

Colour: Titanium Dioxide IP

Appropriate overages of vitamin added to compensate for loss on storage.

60 Diclofenac Sodium & Each enteric coated tablet contains:

Serratiopeptidase Tablets Diclofenac Sodium IP 50mg

Serratiopeptidase 10mg eq. to 20,000 serratiopeptidase units

Colour: Titanium Dioxide IP & Sunset yellow FCF

59 Cholecalciferol Tablets Each uncoated dispersible tablet contains:

Cholecalciferol IP 60,000 IU

58 Folic Acid Tablets IP Each uncoated tablet contains:

Folic Acid IP 5mg

Appropriate overages of vitamin added.

57 Serratiopeptidase Tablets 2.5mg Each enteric coated tablet contains:

Serratiopeptidase 2.5mg

(eq. to 5000 serratiopeptidase units)

Colour: Titanium Dioxide IP

Appropriate overages added.

56 Serratiopeptidase Tablets 5mg Each enteric coated tablet contains:

Serratiopeptidase 5mg

(eq. to 10,000 serratiopeptidase units)

Colour: Titanium Dioxide IP & Iron Oxide Red

Appropriate overages added.

55 Serratiopeptidase Tablets 10mg Each enteric coated tablet contains:

Serratiopeptidase 10mg Page 118 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

(eq. to 20,000 serratiopeptidase units)

Colour: Titanium Dioxide IP, Brilliant blue &

Tartrazine yellow

Appropriate overages added.

54 Serratiopeptidase with Diclofenac Each enteric coated tablet contains: DCG (I) +

Sodium Tablets Diclofenac Sodium IP 50mg

Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units)

Colour: Titanium Dioxide IP & Sunset yellow FCF

53 Gabapentin & Methylcobalamin Tabs Each film coated tablet contains: DCG (I) +

Gabapentin USP 300mg

Methylcobalamin 500mcg

Colour: Ponceau 4R & Titanium Dioxide IP

52 Vitamin with Minerals Caps Each capsule contains: b-Carotene 0.8mg

eq. to 4.0mg of 20% w/w)

Vitamin A (as acetate) IP 2500IU

Vitamin D3 IP 200IU

Vitamin E Acetate (50%) 12.5IU

Folic Acid IP 0.5mg

Vitamin C (coated) 40mg

Vitamin B1 mononitrate IP 2.5mg

Vitamin B2 IP 2.5mg

Niacinamide IP 25mg

Pyridoxine Hydrochloride IP 1.5mg

Cyanocobalamin IP 2.5mcg

Dicalcium Phosphate IP eq. to Calcium 200mg

Potassium Iodide IP eq. to Iodide 100mcg

Ferrous fumarate IP eq. to elemental Iron 8mg

Magnesium Oxide IP eq. to Magnesium 12.5mg

Zinc Sulphate monohydrate USP eq. to Zinc 7mg

Copper Sulphate Pentahydrate IP'66 eq. to Copper 0.7mg

Selenium Dioxide eq. to Selenium 10mcg

51 Methylcobalamin Injection Each ml contains: Page 119 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Methylcobalamin 500mcg

Benzyl Alcohol IP'85 2% w/v

(as preservative)

Water for Injection IP q.s.

50 Ascorbic Acid Injection IP Each 2ml contains:

Ascorbic Acid IP 500mg

49 Diclofenac Sodium injection IP Each ml contains:

Diclofenac Sodium IP 25mg

48 Sodiium Chloride drops Each ml contains:

Sodium Chloride IP 0.65% w.v in distilled water made isotonic and buffered added Benzalkonium chloride solution IP. Eq. to Benzalkonium chloride 0.001% w/v and Phenyl Mercuric Acetate

IP. 0.002% w/v as preservative

47 Diclofenac Sodium injection IP Each ml contains:

Diclofenac Sodium IP 25mg

Benzyl Alcohol IP 4% w/v

Water for Injection IP q.s.

46 Tramadol Injection 50mg Each ml contains:

Tramadol Hydrochloride BP 50mg

Water for Injection IP q.s.

45 Diclofenac Sodium injection IP Each ml contains:

Diclofenac Sodium IP 25mg

Benzyl alcohol IP 85 4% w/v

(as preservative)

Water for Injection IP q.s.

44 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 500mg

Water for Injection IP q.s.

43 Tranexamic Acid Injection B.P Each 10ml contains:

Tranexamic Acid BP 1000mg

42 Pregabalin & Methylcobalamin Caps Each hard gelatin capsule contains:

Pregabalin 75mg

Methylcobalamin 750mcg

(as film coated tablet) colour: iron Oxide Red

Approved colours used in capsule shell.

41 Pregabalin & Methylcobalamin Caps Each hard gelatin capsule contains:

Pregabalin 150mg

Methylcobalamin 750mcg

(as film coated tablet) Page 120 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS colour: iron Oxide Red

Approved colours used in capsule shell.

40 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) + folic Acid & Vitamin B6 Caps Methylcobalamin 500mcg

39 Calcium Carbonate, Vitamin D3 Each 5ml of suspension contains:

& Lysine Suspension 625mg calcium carbonate BP from an organic source (Oyster shell) eq. to elemental calcium 250mg

Cholecalciferol BP 125 IU

Lysine Hydrochloride BP 50mg colour: Erythrosine supra

38 Iron with vitanins Syrup Each 10ml contains:

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride IP 3mg

Folic Acid IP 15mg

(containing Methylcobalamin & Folic Acid as as film coated tablets)

Colour: Titanium Dioxide IP & Iron Oxide Red

Appropriate overages of vitamins are added.

Carbonyl Iron eq. to elemental Iron 60mg

Zinc Gluconate USP eq. to elemental zinc 11mg

Cyanocobalamin BP 5mcg

Lysine Hydrochloride USP 25mg

Selenium (as sodium selenite USP) 60mcg

Folic Acid BP 1mg

. Appropriate overages of vitamins is added .

37 Iron with vitamins Syrup Each hard gelatin capsule contains:

Carbonyl Iron eq. to elemental Iron 100mg

Folic Acid BP 1.5mg

Cyanocobalamin BP 15mcg

Ascorbic Acid BP 75mg

Zinc Sulphate Monohydrate USP 61.8mg

36 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) + folic Acid & Vitamin B6 Caps Methylcobalamin 500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride BP 3mg

Folic Acid BP 1.5mg

(containing Methylcobalamin & Folic Acid as Page 121 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS as film coated tablets)

Colour: Titanium Dioxide BP & Iron oxide Red

Approved overages are added.

35 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) + folic Acid & Vitamin B6 Caps Methylcobalamin 500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride BP 3mg

Thiamine Mononitrate BP 10mg

Folic Acid BP 1.5mg

(containing Methylcobalamin & Folic Acid as film coated tablets)

Colour: Titanium Dioxide BP & Iron oxide Red

Approved overages are added.

34 Methylcobalamin, Alpha Lipoic Each hard gelatin capsule contains: DCG (I) + folic Acid & Vitamin B6 Caps Methylcobalamin 1500mcg

Alpha Lipoic Acid USP 100mg

Pyridoxine Hydrochloride BP 3mg

Folic Acid BP 1.5mg

(Containing Methylcobalamin & Folic Acid as film coated tablets)

Colour: Titanium Dioxide BP & Iron oxide Red

Approved overages are added.

33 Multivitamin & Minerals Tablets Each film coated tablet contains:

Vitaamin A Concentrate (Powder form) BP

(as acetate) 2500 IU

Thiamine Mononitrate BP 1mg

Vitamin B2 BP 1.5mg

Vitamin B6 BP 1.0mg

Vitamin B12 BP 1mcg

Cholecalciferol BP 50mg

Vitamin E Acetate BP 7.5mg

Calcium D Pantothenate BP 5.0mg

Folic Acid BP 0.15mg

Nicotinamide BP 20mg

Biotin BP 30mcg

Zinc Oxide BP eq. to Zinc 15mg

Potassium Iodide BP eq. to iodine 0.15mg

Ferrous fumarate BP eq. to Iron 10mg

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Magnesium Oxiden Light BP eq. to Magnesium 100mg

Manganese Sulphate USP eq. to Manganese 2.5mg

Cupric Oxide eq. to Copper 2.0mg

Calcium Phosphate Dibasic BP eq. to Calcium 162mg

Phosphorous 125mg

Potassium Chloride BP eq. to Potassium 40mg

Chloride 36.3mg

Chromic Chloride USP eq. to Chromium 25mcg

Sodium Molybdate eq, to Molybdenum 25mcg

Sodium Selenate (eq. to Selenium) 30mcg

Nickel Sulphate eq. to Nickel BP 5mcg

Stannous Chloride Dihydrate BP eq. to Tin 10mcg

Colloidal Silicon Dioxide BP eq. to Silicon 2mg

Sodium Meta Vanadate eq. to Vanadate 10mcg

Sodium borate BP eq. to boron 150mcg

Colour: iron Oxide Red, Iron oxide yellow &

Titanium Dioxdie IP

32 Methylcobalamin Tablets Each film coated tablet contains:

Methylcobalamin 1500mcg

Colour: Iron Oxide red & Titanium Dioxide IP

31 Methylcobalamin Tablets Each film coated tablet contains:

Methylcobalamin 500mcg

Colour: Iron Oxide red, Iron Oxide yellow &

Titanium Dioxide IP

30 Biotin Tablets 5mg Each film coated tablet contains:

Biotin BP 5mcg

Colour: Titanium Dioxide BP

29 Methylcobalamin Tablets 500mcg Each film coated tablet contains:

Methylcobalamin 500mcg

Colour: Iron oxide red, Iron oxide yellow & Page 123 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Titanium Dioxide BP

28 Methylcobalamin Tablets 1500mcg Each film coated tablet contains:

Methylcobalamin 1500mcg

Colour: Iron oxide red, Iron oxide yellow &

Titanium Dioxide BP

27 Ascorbic Acid Tablets B.P Each uncoated tablet contains:

Ascorbic Acid BP 100mg

26 Serratiopeptidase & Diclofenac Each enteric coated tablet contains:

Sodium Tablets Diclofenac Sodium BP 50mg

Serratiopeptidase 10mg

(eq. to 20,000 serratiopeptidase units)

Colour:Titanium Dioxide BP & Sunset yellow FCF

25 Phenytoin Injection B.P Each ml contains:

Phenytoin BP 50mg

Water for Injection BP q.s.

24 Fluphenazine Decanoate Injection Each ml contains:

Fluphenazine Decanoate BP 25mg

Benzyl Alcohol BP 1.5% v/v

(as preservative)

Sesame Oil q.s

23 Clindamycin Injection BP Each ml contains:

Clindamycin Phosphate BP eq. to Clindamycin 150mg

Water for Injection BP q.s.

22 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 500mg

Water for Injection BP q.s.

21 Diclofenac Sodium Injection BP Each ml contains:

Diclofenac Sodium BP 25mg

Benzyl Alcohol BP 4% w/v

(as preservative)

20 Tramadol Hydrochloride Injection Each 2ml contains:

Water for Injection BP q.s.

19 Tramadol Hydrochloride Injection Each ml contains:

Tramadol hydrochloride BP 100mg

Water for Injection BP q.s.

Tramadol hydrochloride BP 50mg

Water for Injection BP q.s.

18 Noradrenaline Injection B.P Each ml contains:

Noradrenaline Acid Tartrate BP 2mg eq. to Noradrenaline 1mg Page 124 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

Water for Injection BP q.s.

17 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 250mg

Water for Injection BP q.s.

16 Methylcobalamin Injection Each ml contains:

Methylcobalamin 1500mcg

Benzyl Alcohol BP 2% w/v

(as preservative)

Water for Injection BP q.s.

15 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 250mg

Water for Injection BP q.s.

14 Tranexamic Acid Injection B.P Each 5ml contains:

Tranexamic Acid BP 250mg

Water for Injection BP q.s.

13 Methylcobalamin Injection 500mcg Each ml contains:

Methylcobalamin 500mcg

Benzyl Alcohol BP 2% w/v

(as preservative)

Water for Injection BP q.s.

12 Adrenaline Bitartrate Inj. IP Each ml contains:

Adrenaline Bitartrate IP eq. to Adrenaline 1mg (1:1000)

11 Chlorpheniramine Maleate Each ml contains:

Injection IP Chlorpheniramine Maleate IP 10mg

10 Frusemide Injection IP Each ml contains:

Frusemide IP 10mg

9Lignocaine HCl Injection IP Each ml contains:

Lignocaine Hydrochloride IP 0.2% w/v

8Lignocaine HCl Injection IP Each ml contains:

Lignocaine Hydrochloride IP 1% w/v

7 Metoclopramide HCl Injection Each 2ml contains:

Anhydrous Metoclopramide HCl IP 10mg

6 Methylegrometrine Maleate Each ml contains:

Injection IP Methyl Egrometrine Maleate IP 200µg

5 Pentazocine Lactate Injection IP Each ml contains:

Pentazocine Lactate IP eq. to Pentazocine 30mg

4 Pentazocine Lactate Injection IP Each ml contains:

Pentazocine Lactate IP eq. to Pentazocine 60mg Page 125 of 252

[Type text]

Kabs Pharma

LIST OF PRODUCTS

S.NO GENERIC NAME COMPOSITION YEAR OF APPROVAL APPROVING AUTHORITY REMARKS

3 Pheniramine Maleate Inj. IP Each ml contains:

2 Promethazine HCl Injection IP Each ml contains:

Pheniramine Maleate IP 22.75mg

Promethazine Hydrochloride IP 25mg

1 Promethazine HCl Injection IP Each ml contains:

Promethazine Hydrochloride IP 50mg

[Type text]

Page 126 of 252

Download