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MODULE 1 |
ADMINISTRATIVE AND PRESCRIBING INFORMATION |
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Module 1.1 |
Forms |
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Application Form (356h) |
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Module 1.2 |
Cover Letter |
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Module 1.3 |
Administrative Information |
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Field copy certification |
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Debarment certification |
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Financial Certification |
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Patent and Exclusivity |
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1.3.5.1 Patent Information |
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1.3.5.2 Patent Certification |
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Module 1.4 |
References |
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Letters of Authorization |
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Module 1.12 |
Basis for Submission |
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Comparison of Generic Drug and Reference-Listed Drug |
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1.12.14 Environmental Impact Analysis Statement |
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1.12.15 Request for waiver |
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Module 1.14 |
Labeling |
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Draft labeling |
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1.14.1.1 Draft Carton and Container Labeling |
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1.14.1.2 Draft Labeling-Side-by Side Labeling Comparison |
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1.14.1.3 Draft Labeling Package Insert |
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Listed Drug Labeling |
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Listed Drug Labeling-Side-by-Side Comparison (PI) |
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RLD Labeling- Label and Container Label |
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MODULE 2 |
QUALITY OVERALL SUMMARY (QOS) |
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Module 2.3 |
Quality Overall Summary |
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2.3.S Drug Substance (Active Pharmaceutical Ingredient) |
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2.3.S.1 General Information |
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2.3.S.2 Manufacture |
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2.3.S.3 Characterization |
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2.3.S.4 Control of Drug Substance |
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2.3.S.5 Reference Standards or Materials |
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2.3.S.6 Container Closure System |
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2.3.S.7 Stability |
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2.3.P Drug Product |
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2.3.P.1 Description and composition of the Drug Product |
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2.3.P.2 Pharmaceutical Development |
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2.3.P.2.1 Components of Drug Product |
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2.3.P.2.1.1 Drug Substance |
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2.3.P.2.1.2 Excipients |
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2.3.P.2.2 Drug Product |
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2.3.P.2.4 Container Closure System |
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2.3.P.3 Manufacture |
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2.3.P.4 Control of Excipients |
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2.3.P.5 Control of Drug Products |
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2.3.P.6 Reference Standards or Materials |
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2.3.P.7 Container Closure System |
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2.3.P.8 Stability |
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Module 2.7 |
Clinical Summary (Bioequivalence) |
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Summary of Biopharmaceutic Studies and Associated Analytical Methods |
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Background and Overview |
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Summary of Results of Individual Studies |
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Comparison and Analyses of Results Across Studies |
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2.7.1.4 Appendix |
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MODULE 3 |
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3.2 Body of Data |
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Module 3.2.S |
DRUG SUBSTANCE |
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3.2.S.1 General Information |
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3.2.S.1.1 Nomenclature |
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3.2.S.1.2 Structure |
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3.2.S.1.3 General Properties |
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3.2.S.2 Manufacture |
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3.2.S.2.1 Manufacturer(s) |
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3.2.S.3 Characterization |
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3.2.S.4 Control of Drug Substance |
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3.2.S.4.1 Testing Specification |
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3.2.S.4.2 Analytical Procedures |
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3.2.S.4.3 Validation of Analytical Procedures |
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3.2.S.4.4 Batch Analysis |
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3.2.S.4.5 Justification of Specification |
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3.2.S.5 Reference Standards or Materials |
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3.2.S.6 Container closure System |
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3.2.S.7 Stability |
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Module 3.2.P |
DRUG PRODUCT |
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3.2.P.1 Description and Composition of the Drug Product |
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3.2.P.2 Pharmaceutical Development |
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3.2.P.3 Manufacture |
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3.2.P.3.1 Manufacturer(s) |
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3.2.P.3.2 Batch Formula |
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3.2.P.3.3 Description of Manufacturing Process and Process Controls |
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3.2.P.3.4 Controls of Critical Steps and Intermediates |
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3.2.P.3.5 Process Validation and /or Evaluation |
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3.2.P.4 Control of Excipients 3.2.P.4.1 Specifications |
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3.2.P.4.2 Analytical Procedures |
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3.2.P.4.3 Validation of Analytical Procedures |
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3.2.P.4.4 Justification of Specification |
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3.2.P.5 Control of Drug Product |
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3.2.P.5.1 Specification |
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3.2.P.5.2 Analytical Procedures |
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3.2.P.5.3 Validation of Analytical Procedures |
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3.2.P.5.4 Batch Analysis |
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3.2.P.5.5 Characterization of Impurities |
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3.2.P.5.6 Justification of Specification |
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3.2.P.6 Reference Standards or Materials |
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3.2.P.7 Container Closure System |
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3.2.P.8 Stability |
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3.2.P.8.1 Stability Summary and Conclusion |
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3.2.P.8.2 Proposed and Executed Stability Protocols |
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3.2.P.8.2.1 Post-approval Stability Protocol and Commitment |
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3.2.P.8.3 Stability Data |
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3.2.A Appendices |
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Module 3.2.R |
REGIONAL INFORMATION |
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3.2.R Drug Substance |
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3.2.R.1.S Executed Batch records for drug Substance |
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3.2.R.2.S Comparability Protocol |
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3.2.R.3.S Method Validation Package |
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3.2.R Drug Product |
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3.2.R.1.P.1 Executed Batch Records |
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3.2.R.1.P.2 Information on components |
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3.2.R.2.P Comparability Protocol |
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3.2.R.3.P Method Validation Package |
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3.2.R.1.P.2 Information on components |
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3.2.R.2.P Comparability Protocol |
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3.2.R.3.P Method Validation Package |
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MODULE 5 |
CLINICAL STUDY REPORTS |
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Module 5.2 |
Tabular Listing of Clinical Studies |
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Module 5.3 |
Clinical Study Reports |
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Bioavailability/ Bioequivalence |
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Comparative BA/BE Study Reports |
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In Vitro-In-Vivo Correlation Study Reports |
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Reports of Bioanalytical and Analytical Methods for Human Studies |
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Case Report Forms and Individual Patient Listing |
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Module 5.4 |
Literature References |
Us toc format, anda products
