Drug Approval Package
Arestin (Minocycline Hydrochloride) Microspheres
Company: OraPharma, Inc.
Application No.: 50-781
Approval Date: 2/16/01
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Approval Letter(s) (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF)
Part 8 (PDF)
Part 9 (PDF)
Part 10 (PDF)
Part 11 (PDF)
Date created: February 20, 2003
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