Drug Approval Package
Lidoderm (Lidocaine) Patch
Company: Hind Health Care, Inc.
Application No.: 20-612
Approval Date: 3/19/1999
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Approval Letter & Approvable Letter (PDF) (1.3 MB)
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Medical Review(s)
Part 1 (PDF) (2.5 MB) Part 4 (PDF) (2.7 MB) Part 2 (PDF) (2.3 MB) Part 5 (PDF) (2.5 MB) Part 3 (PDF) (2.8 MB) Part 6 (PDF) (2.9 MB) -
Chemistry Review(s) & Pharmacology Review(s) (PDF) (2 MB)
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Statistical Review(s)
Part 1 (PDF) (2.1 MB)
Part 2 (PDF) (1.6 MB) -
Microbiology Review(s) (PDF) (742 KB)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (1.9 MB)
Part 2 (PDF) (2 MB) -
Administrative Document(s)/Correspondence
Part 1 (PDF) (2.2 MB) Part 4 (PDF) (2.8 MB) Part 2 (PDF) (2 MB) Part 5 (PDF) (3 MB) Part 3 (PDF) (1.9 MB)
Date created: March 30, 2001; last update: July 5, 2005
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