Drug Approval Package
Trovan Tablets & Trovan I.V. (Trovafloxacin Mesylate & Alatrofloxacin Mesylate)
Company: Pfizer
Application No.: 20-759 & 20-760
Approval Date: 12/18/1997
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Approval Letter & Printed Labeling (PDF) (3.5 MB)
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Medical Review(s) (PDF)
Part 1 (2.5 MB) Part 13 (3.2 MB) Part 24 (3 MB) Part 2 (3 MB) Part 14 (3.3 MB) Part 25 (3 MB) Part 3 (3 MB) Part 15 (2.8 MB) Part 26 (2.8 MB) Part 4 (2.9 MB) Part 16 (3.2 MB) Part 27 (3.2 MB) Part 5 (3.4 MB) Part 17 (2.6 MB) Part 28 (3.2 MB) Part 6 (3 MB) Part 18 (3.3 MB) Part 29 (3 MB) Part 7 (3 MB) Part 19 (2.8 MB) Part 30 (3 MB) Part 8 (2.8 MB) Part 20 (2.9 MB) Part 31 (2.9 MB) Part 9 (3.2 MB) Part 21 (2.7 MB) Part 32 (2.9 MB) Part 10 (2.7 MB) Part 22 (3.3 MB) Part 33 (2.9 MB) Part 11 (3 MB) Part 23 (3.9 MB) Part 34 (2.7 MB) Part 12 (2.7 MB) -
Chemistry Review(s) (PDF) (893 KB)
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Pharmacology Review(s) (PDF)
Part 1 (2.7 MB)
Part 2 (2.6 MB) -
Statistical Review(s) (PDF)
Part 1 (2.9 MB)
Part 2 (2.9 MB)
Part 3 (3.4 MB)
Part 4 (2.5 MB)
Part 5 (2.6 MB)
Part 6 (3.3 MB)
Part 7 (2.7 MB)
Part 8 (3.1 MB)
Part 9 (3.3 MB)
Part 10 (3.1 MB) -
Microbiology Review(s) (PDF)
Part 1 (3.1 MB)
Part 2 (3 MB)
Part 3 (2.8 MB)
Part 4 (2.6 MB)
Part 5 (3.2 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (474 KB)
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Administrative Document(s)/Correspondence (PDF)
Part 1 (2.4 MB)
Part 2 (2.4 MB)
Date created: August 05, 2003; last updated: July 1, 2005
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