Drug Approval Package
Periostat (Doxycycline Hyclate USP) Capsules
Company: Colla Pharmaceuticals, Inc.
Application No.: 50744
Approval Date: 9/30/1998
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Approval Letter (PDF) (232 KB)
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Medical Review(s) and Chemistry Reviews (PDF) (1.8 MB)
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Enviornmental Assesment (PDF) (1.7 MB)
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Pharmacology Review(s) (PDF) (1.5 MB)
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Statistical Reviews(s) and Microbiology Review(s) (PDF) (1.6 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.1 MB)
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Administrative Documents(s) and Correspondence (PDF) (2.3 MB)
Date created: March 08, 2001; last update: July 5, 2005
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