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Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

April 25, 2006

Briefing Information

Cellegy Pharmaceuticals, Inc.

Cellegesic™ Nitroglycerin Ointment 0.4%

NDA 21-359


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Cellegy Pharmaceuticals Briefing Document


Food and Drug Administration

Briefing Document

NDA 21-359

1.  Division Director’s Questions to the Committee

2.  Division Director Memo 12/20/04

3.  Division Director Memo 12/22/04

4.  Division Director Memo 12/23/04

5.  Medical/Statistical Review 02/27/02

6.  Division Director Memo 04/29/02

7.  Medical Review

8.  Statistical Review 

9.  Medical Review of sponsor’s response to NA letter 05/26/05

Page last updated April 24, 2006 kkhorizonal rule
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