Drug Approval Package
Cleocin 3 Vaginal Cream (Clindamycin Phosphate)
Company: Pharmacia & Upjohn
Application No.: 050-680/S002
Approval Date: 3/2/1998
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Approval Letter (PDF) (261 KB)
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Medical Review(s)
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2.3 MB)
Part 3 (PDF) (1.9 MB) -
Pharmacology Review(s) (PDF) (204 KB)
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Statistical Review(s) (PDF) (2.9 MB)
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Microbiology Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (1.4 MB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (1.4 MB)
Part 2 (PDF) (1.9 MB)
Date created: March 30, 2001; last updated: July 1, 2005
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