Drug Approval Package
Cenestin (Synthetic Conjugated Estrogens, A) Tablets
Company: Duramed Pharmaceuticals, Inc.
Application No.: 20-992
Approval Date: 3/24/1999
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Approval Letter & Final Printed Labeling (PDF) (2.5 MB)
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Medical Review(s)
Part 1 (PDF) (2.7 MB)
Part 2 (PDF) (2.4 MB) -
Chemistry Review(s) & Pharmacology Review(s) (PDF) (2.2 MB)
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Statistical Review(s) (PDF) (2.9 MB)
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Microbiology Review(s) (PDF) (204 KB)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (2.5 MB)
Part 2 (PDF) (2.6 MB)
Part 3 (PDF) (2.8 MB)
Part 4 (PDF) (2.7 MB) -
Administrative Document(s)
Part 1 (PDF) (2.6 MB) Part 5 (PDF) (2.8 MB) Part 9 (PDF) (1.3 KB) Part 2 (PDF) (2.2 MB) Part 6 (PDF) (2.8 MB) Part 3 (PDF) (2.8 MB) Part 7 (PDF) (2.3 MB) Part 4 (PDF) (2.5 MB) Part 8 (PDF) (2.7 MB) -
Correspondence
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2.4 MB)
Part 3 (PDF) (2.4 MB)
Date created: March 30, 2001; last update: July 5, 2005
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