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Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

Document ID: FDA-2008-N-0341-0006
Document Type: Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Confidential Business Information, Drugs, Reporting and Recordkeeping Requirements
Federal Register Number: E9-17963
CFR Citation: 21 CFR 314
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Details Information

Document Subtype: NFR-Notice of Final Rule
Received Date: July 27 2009, at 01:44 PM Eastern Daylight Time
Start-End Page: 37163 - 37168
Page Count: 6
Comment Start Date: July 28 2009, at 12:00 AM Eastern Standard Time

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