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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-0341-0001
Document Type: Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Confidential Business Information, Drugs, Reporting and Recordkeeping Requirements
Federal Register Number: E8-22833
CFR Citation: 21 CFR 314
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Details Information

Document Subtype: NFR-Notice of Final Rule
Received Date: September 26 2008, at 07:50 AM Eastern Daylight Time
Start-End Page: 56487 - 56491
Page Count: 5
Comment Start Date: September 29 2008, at 12:00 AM Eastern Standard Time
Comment Due Date: December 15 2008, at 11:59 PM Eastern Standard Time

Comments

   
Total: 2
GlaxoSmithKline - Comment
Posted: 12/11/2008     ID: FDA-2008-N-0341-0004

Dec 15,2008 11:59 PM ET
AstraZeneca - Comment
Posted: 12/09/2008     ID: FDA-2008-N-0341-0003

Dec 15,2008 11:59 PM ET

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