Drug Approval Package
Levaquin (Levofloxacin) Tablets & Injection
Company: R. W. Johnson
Application No.: 020634/S04 & 0202635/S03
Approval Date: 12/17/1998
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Approval Letter (PDF) (258 KB)
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Printed Labeling
Part 1 (PDF) (2.4 MB)
Part 2 (PDF) (2.4 MB) -
Medical Review(s) (PDF) ( MB)
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Chemistry Review(s), Environmental Assessment & Statistical Review(s) (PDF) (1.7 MB)
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Microbiology Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.6 MB)
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Administrative Document(s)/Correspondence (PDF) (1.5 MB)
Date created: March 30, 2001; last updated: July 1, 2005
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