Drug Approval Package
Lamisil (Terbinafine Hydrochloride) Cream
Company: Novartis Consumer Health, Inc.
Application No.: 20-980
Approval Date: 3/9/1999
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Approval Letter (PDF) (985 KB)
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Medical Review(s)
Part 1 (PDF) (1.8 MB) Part 4 (PDF) (3 MB) Part 2 (PDF) (2.3 MB) Part 5 (PDF) (3 MB) Part 3 (PDF) (2.4 MB) Part 6 (PDF) (2.4 MB) -
Chemistry Review(s) & Pharmacology Review(s) (PDF) (1.2 MB)
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Statistical Review(s)
Part 1 (PDF) (2.1 MB)
Part 2 (PDF) (1.9 MB)
Part 3 (PDF) (1.8 MB) -
Microbiology Review(s) (PDF) (1.1 MB)
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Bioequivalence Review(s) (PDF) (504 KB)
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Administrative Document(s)
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2.9 MB)
Part 3 (PDF) (2.3 MB)
Part 4 (PDF) (2.6 MB) -
Correspondence
Part 1 (PDF) (2.5 MB)
Part 2 (PDF) (2.4 MB)
Part 3 (PDF) (2 MB)
Date created: March 30, 2001; last update; July 5, 2005
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