Drug Approval Package
Floxin Otic (Ofloxacin)
Solution
Company: Daiichi Pharmaceutical
Application No.: 020799
Approval Date: 12/16/1997
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Approval Letter(s) (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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Environmental Assessment (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Date created: October 7, 2004
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