Drug Approval Package
Spectracef
(Cefditoren Pivoxil) Tablets
Company: TAP Pharmaceutical Products Inc.
Application No.: 21-222
Approval Date: 8/29/01
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Correspondence (PDF)
Date created: December 07, 2001
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