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[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
1
Module 1
Regional Administrative Information
................................
................................
.........................
1
x
1.1
Forms
................................
................................
................................
................................
.....................
1
x
1.1.1
FDA Form 1571
................................
................................
................................
....
(not applicable)
1.1.2
FDA Form 356h
................................
................................
................................
..............................
1
x
1.1.3
User Fee Cover Sheet (FDA Form 3397)
................................
................................
.......................
1
x
1.1.4
Annual Report Transmittal Form (FDA Form 2252)
................................
............
(not applicable)
1.1.5
Advertising and Promotional Labelli
ng Form (FDA Form 2253)
.........................
(not applicable)
1.1.6
Transmittal of Labels and Circulars (FDA Form 2567)
................................
........
(not applicable)
1.2
Cover Letter
................................
................................
................................
................................
.........
1
x
Comprehensive
Table of Contents
for Modules 1
5
................................
................................
............
1
x
1.3
Administrative Information
................................
................................
................................
...................
1
x
1.3.1
Contact/Sponsor Information
................................
................................
................................
......
1
x
1.3.2
Field Copy Certification
................................
................................
................................
.................
1
x
1.3.3
Debarment Certification
................................
................................
................................
.................
1
x
1.3.4
Certification:
Financial
Interests and Arrangements of Clinical Investigators (FDA Form 3454)
.
1
x
1.3.5
Patent & Exclusivity
................................
................................
................................
.......................
1
x
1.3.5.1
Patent Information
(FDA Form 3542a)
................................
................................
.................
1
x
1.3.5.2
Patent Certification
................................
................................
................................
................
1
x
1.3.5.3
S
tatement of Claimed Exclusivity
................................
................................
.........................
1
x
1.4
References
................................
................................
................................
................................
.............
1
x
1.4.1
Letters of Authorization
................................
................................
................................
..................
1
x
1.4.2
Statement of Right of Reference
................................
................................
............
(not applicable)
1.4.3
List of Authorized Persons to Incorporate by Reference
................................
.......
(not applicable)
1.4.4
Cross Reference to Other Applications & Previously
Submitted Information
................................
1
x
1.5
Applicati
on Status
................................
................................
................................
................................
..
1
x
1.5.1
IND Withdrawal Request
................................
................................
................................
................
1
x
1.5.2
Inactivation Request
................................
................................
................................
.......................
1
x
1.5.3
Reactivation Request
................................
................................
................................
......................
1
x
1.5.4
Reinstatement Request
................................
................................
................................
....................
1
x
1.5.5
Withdrawal of an Unapproved Application
................................
................................
....................
1
x
1.5.6
Withdrawal of a Listed Drug
................................
................................
................................
..........
1
x
1.5.7
Request for Withd
rawal of Application Approval
................................
................................
..........
1
x
1.5.8
Other Correspondence
................................
................................
................................
....................
1
x
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
2
Module 1
Regional Administrative Information
(continued)
................................
................................
.....
1
x
1.6
Meetings
................................
................................
................................
................................
.................
1
x
1.6.1
Meeting Request
................................
................................
................................
.............................
1
x
1.6.2
Meeting Background Materials
................................
................................
................................
.......
1
x
1.6.3
Correspondence Regarding Meetings
................................
................................
.............................
1
x
1.7
Fast Track
................................
................................
................................
.....................
(not appl
icable)
1.8
Special Protocol Assessment (SAP) Request
................................
................................
(not applicable)
1.9
Pediatric Administrative Information
................................
................................
................................
.....
1
x
1.9.1
Request for
Waiver
................................
................................
............................
(not applicable)
1.9.2
Request for
Deferral
................................
................................
..........................
(not applicable)
1.9.3
Request for Pediatric Exclusivity Determination
................................
............
(not applicable)
1.9.4
Propo
sed Pediatric Study Request & Amendments
................................
........
(not applicable)
1.9.5
Proposal for Written Agreement
................................
................................
......
(not applicable)
1.9.6
Other Correspondence Regarding Pediatric Exclusivity or Study Plans
................................
.........
1
x
1.10
Dispute Resolutions
................................
................................
................................
.......
(not applicable)
1.10.1
Request for Dispute Resolution
1.10.2
Correspo
ndence Relating to Dispute Resolution
1.11
Information Amendment (not covered under Modules 2
–
5)
................................
........
(not applicable)
1.11.1
Quality
1.11.2
Safety
1.11.3
Efficacy
1.12
Other Correspondence
................................
................................
................................
............................
1
x.
1.12.1
Pre
IND Correspondence
................................
................................
................................
................
1
x
1.12.2
Request to Charge
................................
................................
................................
..
(not applicable)
1.12.3
Notification of Charging Unde
r Treatment IND
................................
....................
(not applicable)
1.12.4
Request for Comments and Advice on an IND
................................
................................
...............
1
x
1.12.5
Request for Waiver
................................
................................
................................
(not applicable)
1.12.6
Exemption from Informed Consent for Emergency Research
...............................
(not applicable)
1.12.7
Public Disclosure Statement for Emergency Care Research
................................
..
(not applica
ble)
1.12.8
Correspondence Regarding Emergency Care Research
................................
.........
(not applicable)
1.12.9
Notification of Discontinuation of Clinical Trial
................................
...................
(not applicable)
1.12.10
Generic Drug Enforcement Act (GDEA) Statement
................................
................................
..
1
x
1.12.11
Basis for Submission Statement
................................
................................
................................
......
1
x
1.12.12
Comparison of Generic Drug and
Reference Listed Drug (RLD)
................................
...................
1
x
1.12.13
Request for Waiver of
in vivo
Studies
................................
................................
.............................
1
x
1.12.14
Environmental Impact Analysis Statement
................................
................................
.....................
1
x
1.12.15
Request for Waiver of
in vivo
Bioavailability Studies
................................
................................
1
x
1.12.16
Field Alert Reports
................................
................................
................................
(not applicable)
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
3
Module 1
Regional Administrative Infor
mation
(continued)
................................
................................
.....
1
x
1.13
Annual Reports
................................
................................
................................
..............
(not applicable)
1.13.1
Summary for Non
Clinical Studies
1.13.2
Summary of Clinical Pharmacology Studies
1.13.3
Summary of Safety Information
1.13.4
Summary of Labelling Changes
1.13.5
Summary of Manufacturing Changes
1.13.6
Summary of Microbiological Change
s
1.13.7
Summary of Other Significant New Information
1.13.8
Individual Study Information
1.13.9
General Investigational Plan
1.13.10
Foreign Marketing History
1.13.11
Distribution Data
1.13.12
Status of Post
Marketing Commitments
1.13.13
Status of Other Post
-
Marketing Studies
1.13.14
Log of Outstanding Regulatory B
usiness
1.14
Labelling
................................
................................
................................
................................
.................
1
x
1.14.1
Draft Labelling
................................
................................
................................
................................
1
x
1.14.1.1
Draft Carton & Container Labels
................................
................................
...........................
1
x
1.14.1.2
Annotated Draft Labelling Text
................................
................................
.........................
1
x
1.14.1.3
Draft Labelling Text
................................
................................
................................
..............
1
x
1.14.1.4
Label Comprehension Studies
................................
................................
.....
(not applicable)
1.14.1.5
Labelling History
................................
................................
................................
...................
1
x
1.14.2
Final Labelling
................................
................................
................................
................................
1
x
1.14.2.1
Final Carton & Contain
er Labels
................................
................................
...........................
1
x
1.14.2.2
Final Package Inserts
................................
................................
................................
.............
1
x
1.14.2.3
Final Labelling Text
................................
................................
................................
..............
1
x
1.14.3
Listed Drug Labelling
................................
................................
................................
.....................
1
x
1.14.3.1
Annotated Comparison with Listed Drug
................................
................................
..........
1
x
1.14.3.2
Approved Labelling Text for Listed Drug
................................
................................
.............
1
x
1.14.3.3
Labelling Text for Reference Listed Drug
................................
................................
.............
1
x
1.14.4
Investigational Drug Labell
ing
................................
................................
................................
.......
1
x
1.14.4.1
Investigator’s Brochure
................................
................................
................................
.........
1
x
1.14.4.2
Investigational Drug Labelling
................................
................................
..............................
1
x
1.14.4.3
FILL IN
................................
................................
................................
................................
1
x
1.14.4.4
FILL IN
................................
................................
................................
................................
1
x
1.14.4.5
Foreign Labelling
................................
................................
.........................
(not applicable)
1.15
Promotional Material
................................
................................
................................
..............................
1
x
1.16
Risk Management Plans
................................
................................
................................
.........................
1
x
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
7
Module 3
Quality
................................
................................
................................
................................
...........
2
x
3.1
Comprehensive
Table of Contents
for Module 3
................................
................................
...................
2
x
3.2
Drug Substance
................................
................................
................................
................................
......
2
x
3.2.S.1
General Information
................................
................................
................................
.......................
2
x
3.2.S.1.1
Nomenclature
................................
................................
................................
....................
2
x
3.2.S.1.2
Structure
................................
................................
................................
............................
2
x
3.2.S.1.3
General Properties
................................
................................
................................
.............
2
x
3.2.S.2
Manufacture
................................
................................
................................
................................
...
2
x
3.2.S.2.1
Manufacturer(s)
................................
................................
................................
.................
2
x
3.2.S.2.2
Description o
f Process and Process Controls
................................
................................
.....
2
x
3.2.S.2.3
Control of Materials
................................
................................
................................
...........
2
x
3.2.S.2.4
Control of Critical Steps and Intermediates
................................
................................
.......
2
x
3.2.S.2.5
Process Validation and/or Evaluation
................................
................................
................
2
x
3.2.S.3
Characterization
................................
................................
................................
.............................
2
x
3.2.S.3.1
Elucidation of Structure and Othe
r Characteristics
................................
............................
2
x
3.2.S.3.2
Impurities
................................
................................
................................
...........................
2
x
3.2.S.4
Control of Drug Substance
................................
................................
................................
.............
2
x
3.2.S.4.1
Specifications
................................
................................
................................
....................
2
x
3.2.S.4.2
Analytical Procedures
................................
................................
................................
........
2
x
3.2.S.4.3
Validation of Analytical Procedures
................................
................................
..................
2
x
3.2.S.4.4
Batch Analyses
................................
................................
................................
..................
2
x
3.2.S.4.5
Justificat
ion of Specification
................................
................................
.............................
2
x
3.2.S.5
Reference Standards or Materials
................................
................................
................................
..
2
x
3.2.S.6
Container/Closure System
s
................................
................................
................................
............
2
x
3.2.S.7
Stability
................................
................................
................................
................................
..........
2
x
3.2.S.7.1
Stability
Summary and Conclusions
................................
................................
..................
2
x
3.2.S.7.2
Post
approval
Stability
Protocol and Commitment
................................
............................
2
x
3.2.S.7.3
Stability
Data
................................
................................
................................
.....................
2
x
3.2.P
Drug Product
................................
................................
................................
................................
..........
3
x
3.2.P.1
Description and Composition of the Drug Product
................................
................................
........
3
x
3.2.P.2
Pharmaceutical Development
................................
................................
................................
........
3
x
3.2.P.2.1
Composition of Drug Product
................................
................................
............................
3
x
3.2.P.2.2
Formulation, Overages, Properties
................................
................................
....................
3
x
3.2.P.2.3
Manufacturing Process Development
................................
................................
................
3
x
3.2.P.2.4
Container/Clos
ure System
................................
................................
................................
.
3
x
3.2.P.2.5
Microbiological Attributes
................................
................................
................................
.
3
x
3.2.P.2.6
Compatibility
................................
................................
................................
.....................
3
x
3.2.P.3
Manufacture
................................
................................
................................
................................
...
3
x
3.2.P.3.1
Manufacturer(s)
................................
................................
................................
.................
3
x
3.2.P.3.2
Batch Formula
................................
................................
................................
...................
3
x
3.2.P.3.3
Description of Manufacturing Process and Process Controls
................................
............
3
x
3.2.P.3.4
Controls of Critical Steps and Intermediates
................................
................................
.....
3
x
3.2.P.3.5
Process Validation
and/or Evaluation
................................
................................
................
3
x
3.2.P.4
Control of Excipients
................................
................................
................................
.....................
3
x
3.2.P.4.1
Specifications
................................
................................
................................
....................
3
x
3.2.P.4.2
Analytical Procedures
................................
................................
................................
........
3
x
3.2.P.4.3
Validation of Analytical Procedures
................................
................................
..................
3
x
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
8
3.2.P.4.4
Justification of Specifications
................................
................................
............................
3
x
3.2.P.4.5
Excipients of Human or Animal Origin
................................
................................
.............
3
x
3.2.P.4.6
Novel Excipients
................................
................................
................................
...............
3
x
3.2.P.5
Control of Drug P
roduct
................................
................................
................................
................
3
x
3.2.P.5.1
Specifications
................................
................................
................................
....................
3
x
3.2.P.5.2
Analytical Procedures
................................
................................
................................
........
3
x
3.2.P.5.3
Validation of Analytical Procedures
................................
................................
..................
3
x
3.2.P.5.4
Batch Analys
e
s
................................
................................
................................
..................
3
x
3.2.P.5.5
Characterization of Impurities
................................
................................
...........................
3
x
3.2.P.5.6
Justification of Specifications
................................
................................
............................
3
x
3.2.P.6
Reference Standards or Materials
................................
................................
................................
..
3
x
3.2.P.7
Container/Closure System
................................
................................
................................
.............
3
x
3.2.P.8
Stability
................................
................................
................................
................................
..........
3
x
3.2.P.8.1
Stability Summary and Conclusions
................................
................................
..................
3
x
3.2.P.8.2
Post
Approval Stability Protocol and Stability Commitments
................................
...........
3
x
3.2.P.8.3
Stability Data
................................
................................
................................
.....................
3
x
3
.
2
.A
Appendices
................................
................................
................................
................................
.............
4
x
3
.
2
.A.1
Facilities and Equipment
................................
................................
................................
................
4
x
3
.
2
.A.2
Adventitious Agents Safety Evaluation
................................
................................
.........................
4
x
3
.
2
.A.3
Novel Excipients
................................
................................
................................
............................
4
x
3
.
2
.R
Regional Information
................................
................................
................................
.............................
4
x
3
.
2
.R.1
Batch Record
s
Lot
#### (STRENGTH)
................................
................................
................................
...............
4
x
L
ot
#### (STRENGTH)
................................
................................
................................
...............
5
x
3.2.R.2
Methods Validation Packet
................................
................................
................................
............
5
x
3.3
Key Literature References
................................
................................
................................
......................
5
x
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
9
Module 4
Non
C
linical Study Reports
................................
................................
................................
.........
6
x
4.1
Comp
rehensive Table of Contents
for Module 4
................................
................................
....................
6
x
4.2
Study Reports
................................
................................
................................
................................
.........
6
x
4.2.1
Pharmacology
................................
................................
................................
................................
.
6
x
4.2.1.1
Primary Pharmacodynamics
................................
................................
................................
..
6
x
4.2.1.2
Secondary Pharmacodynamics
................................
................................
..............................
6
x
4.2.1.3
Safety Pharmacology
................................
................................
................................
.............
6
x
4.2.1.4
Pharmacodynamic Drug Interactions
................................
................................
.....................
6
x
4.2.2
Pharmacokinetics
................................
................................
................................
............................
6
x
4.2.2.1
Analytical Methods and Va
lidation Reports
................................
................................
..........
6
x
4.2.2.2
Absorption
................................
................................
................................
.............................
6
x
4.2.2.3
Distribution
................................
................................
................................
............................
6
x
4.2.2.4
Metabolism
................................
................................
................................
............................
6
x
4.2.2.5
Excretion
................................
................................
................................
...............................
6
x
4.2.2.6
Pharmacokinetic Drug Interactions
................................
................................
........................
6
x
4.2.2.7
Other Pharmacokinetic Studies
................................
................................
..............................
6
x
4.2.3
Toxicology
................................
................................
................................
................................
......
6
x
4.2.3.1
Single
Dose Toxicity
................................
................................
................................
.............
6
x
4.2.3.2
Repeat
Dose Toxicity
................................
................................
................................
............
6
x
4.2.3.3
Genotoxicity
................................
................................
................................
..........................
6
x
4.2.3.3.1
In vitro
Studies
................................
................................
................................
..........
6
x
4.2.3.3.2
In vivo
Studies
................................
................................
................................
...........
6
x
4.2.3.4
Carcinogenicity
................................
................................
................................
......................
6
x
4.2.3.5
Reproductive and Development Toxicity
................................
................................
..............
6
x
4.2.3.5.1
Fertility and Embryonic Development
................................
................................
......
6
x
4.2.3.5.2
Embryo
Fetal Development
................................
................................
......................
6
x
4.2.3.5.3
Pre
and Post
natal Development & Maternal Function
................................
............
6
x
4.2.3.5.4
Offspring, Juvenile, Second &
Third
Generation Studies
................................
.........
6
x
4.2.3.6
Local Tolerance
................................
................................
................................
.....................
6
x
4.2.3.7
Other Toxicity Studies
................................
................................
................................
...........
6
x
4.2.3.7.1
Antigenicity
................................
................................
................................
...............
6
x
4.2.3.7.2
Immunogenicity
................................
................................
................................
........
6
x
4.2.3.7.3
Mechanistic Studies (not included elsewhere)
................................
...........................
6
x
4.2.3.7.4
Dependence
................................
................................
................................
...............
6
x
4.2.3.7.5
Metabolites
................................
................................
................................
................
6
x
4.2.3.7.6
Impurities
................................
................................
................................
..................
6
x
4.2.3.7.7
Other
................................
................................
................................
..........................
6
x
4.3
Literature References
................................
................................
................................
..............................
6
x
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
12
•
Protocol
####
(continued)
................................
................................
..............
1
5
•
A
ppendix 16.2
–
Subject Data Listings
................................
.............................
1
5
2
•
Appendix 16.2.1
–
Discontinued Subjects (none)
................................
.............
1
5
3
•
Appendix 16.2.2
–
Protocol Deviations
–
Blood Samples
................................
.
1
5
5
•
Appendix 16.2.3
–
Subjects Excluded from Analysis (none)
............................
1
5
7
•
Appendix 16.2.4
–
Demographic Data &
Baseline Characteristics
...................
1
5
9
•
Appendix 16.2.5
–
Drug Concentration Data
................................
....................
1
5
12
•
Appendix 16.2.6
–
Individual Data
................................
................................
...
1
5
48
•
Appendix 16.2.7
–
Adverse Event Listings
................................
.......................
1
5
93
•
Appendix 16.2.8
–
Listing of Individual Lab Measurements
............................
1
5
103
•
Appendix 16.2.9
–
Stat
istical Analysis
................................
..............................
1
5
177
•
Appendix 16.3
–
Case Report Forms (CRF)
................................
.....................
1
5
196
•
Appendix 16.3.1
–
CRFs for Deaths, Other Serious Adverse Events, &
Withdrawals for AE (none)
................................
................................
...............
1
5
196
•
Appendix 16.3.2
–
Other CRFs Submitted (NA)
................................
..............
1
5
198
•
Appendix 16.4
–
Individual S
ubject Data Listings
................................
............
1
5
199
•
Appendix 16.5
–
Analytical Report
................................
................................
...
1
5
200
•
Appendix 16.6
–
Validation Report
................................
................................
..
1
5
365
5.3.1.2.2
REFERENCE LISTED DRUG SPONSOR STUDIES
................................
.........
1
6
x
•
FILL IN AS NEEDED
: Summary Basis of Approval Review
.......................
1
6
x
•
FILL IN AS NEEDED
: Summary Basis of App
roval Review
.......................
1
6
x
•
FILL IN AS NEEDED
: Summary Basis of Approval Review
.......................
1
6
x
5.3.1.2.3
Published Studies
................................
................................
................................
......
1
6
x
5.3.1.2.4
Summary
................................
................................
................................
...................
1
6
x
5.3.1.3
In vitro/In vivo
Correlation (IV/IVC)
................................
................................
.....................
1
6
x
5.3.1.4
Bioanalytical and Analytical Methods
................................
................................
...................
1
6
x
5.3.2
Reports of Studies Pertinent to Human PK
................................
................................
.....................
1
6
x
5.3.2.1
Plasma
Protein Binding Study Reports
................................
................................
..................
1
6
x
5.3.2.2
Hepatic Metabolism/Drug Interactions
................................
................................
..................
1
6
x
5.3.2.3
Studies Using other Human Materials
................................
................................
...................
1
6
x
5.3.3
Reports of Human PK Studies
................................
................................
................................
........
1
6
x
5.3.3.1
Healthy Subject PK and Tolerability
................................
................................
.....................
1
6
x
5.3.3.2
Patient PK and Initial Tolerability
................................
................................
.........................
1
6
x
5.3.3.3
Intrinsic Factor
PK
................................
................................
................................
.................
1
6
x
5.3.3.4
Extrinsic Factor PK
................................
................................
................................
...............
1
6
x
5.3.3.5
Population PK
................................
................................
................................
........................
1
6
x
5.3.4
Reports of Human PD Studies
................................
................................
................................
.......
1
6
x
5.3.4.1
Healthy Subject PD and PK/PD Studies
................................
................................
................
1
6
x
5.3.4.2
Patient PD and PK/PD
................................
................................
................................
...........
1
6
x
[CLI
ENT NAME]
NDA
[##,###]
[PRODUCT NAME, STRENGTH[
CONFIDENTIAL
Module 1
–
Overall Table of Contents
Overall CTD Table of Contents
Module
Description
Vol
Page
13
5.3.5
Reports of Efficacy and Safety Studies
................................
................................
...........................
1
6
x
5.3.5.1
Controlled Clinical Studies on Indication
................................
................................
..............
1
6
x
5.
3.5.1.A
INDICATION # 1
................................
................................
................................
.....
1
6
x
5.3.5.1.A.1
CLIENT
Studies
................................
................................
...............................
1
6
x
5.3.5.1.A.2
NDA
##,###
Sponsor Studies
................................
................................
...........
1
6
x
5.3.5.1.A.3
Published Studies
................................
................................
..............................
1
6
x
5.3.5.1.A.4
Summary
................................
................................
................................
...........
1
6
x
5.3.5.3.1.B
INDICATION # 2
................................
................................
................................
.....
1
6
x
5.3.5.1.B.1
CLIENT
Studies
................................
................................
...............................
1
6
x
5.3.5.1.B.2
NDA
##,###
Sponsor Studies
................................
................................
...........
1
6
x
5.3.5.1.B.3
Published Studies
................................
................................
..............................
1
6
x
5.3.5.1.B.4
Summary
................................
................................
................................
...........
1
6
x
5.3.5.2
Uncontrolled Clinical Studies
................................
................................
................................
1
6
x
5.3.5.2.1
CLIENT
Studies
................................
................................
................................
.......
1
6
x
5.3.5.2.2
NDA
##,###
Sponsor Studies
................................
................................
....................
1
6
x
•
Summary Basis of Approval: Clinical Review
................................
.................
1
6
x
5.3.5.2.3
Published Studies
................................
................................
................................
......
1
6
x
5.3.5.2.4
Summary
................................
................................
................................
...................
1
6
x
5.3.5.3
Reports of Analyses of Data from More than One Study
................................
......................
1
6
x
5.3.5.3.1
Integrated Summary of Safety
................................
................................
...................
1
6
x
5.3.5.3.1.A
INDICATION # 1
................................
................................
................................
.....
1
6
x
5.3.5.3.1.B
INDICATION # 2
................................
................................
................................
.....
1
6
x
5.3.5.3.2
Integrated Summary of Efficacy
................................
................................
................
1
6
x
•
INDICATION # 1
................................
................................
.............................
1
6
x
•
INDICATION # 2
................................
................................
.............................
1
6
x
5.3.5.4
O
ther Clinical Study Reports
................................
................................
................................
.
1
7
x
5.3.6
Reports of Post
Marketing Experience
................................
................................
...........................
17
x
5.3.6.1
Regulatory History of
NDA
##,###
................................
................................
.......................
17
x
5.3.6.2
Generic Approvals
................................
................................
................................
.................
17
x
5.3.6.3
Safety Data from Post
Marketing Surveillance
................................
................................
.....
17
x
5.3.6.3.1
Foreign Marketing Data in Support of the Original NDA
................................
.........
17
x
5.3.6.3.2
US Po
st
Marketing Surveillance Data
................................
................................
.......
17
x
5.3.7
Case Report Forms (CRF)/Individual Patient Listings
................................
................................
...
1
7
x
5.3.7.1
Protocol
#####
–
BE Study
................................
................................
................................
...
17
x
5.3.7.2
Protocol
#####
–
Food
Effect Study
................................
................................
.....................
17
x
5.4
Literature References
................................
................................
................................
..............................
18
x
Literature References (continued)
................................
................................
................................
..........
19
x