C79161Level 6

Module 1: Annual Report

**Semantic type:** Regulation or Law

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C79237Summary for Nonclinical Studies

C79238Summary of Clinical Pharmacology Information

C79239Summary of Safety Information

C79240Summary of Labeling Changes

C79241Summary of Manufacturing Changes

C79242Summary of Microbiological Changes

C79243Summary of Other Significant New Information

C79244Individual Study Information

C79245General Investigational Plan

C79246Foreign Marketing History

C79247Distribution Data

C79248Status of Postmarketing Study Commitments

C79249Status of Other Postmarketing Studies

C79250Log of Outstanding Regulatory Business

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