Drug Approval Package
Diclofenac
Sodium Ophthalmic Solution 0.1%
Company: Alcon Laboratories, Inc.
Application No.: 020809
Approval Date: 5/4/1998
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Approval Letter(s) & Final Printed Labeling (PDF) (591 KB)
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Medical Review(s)
Part 1 (PDF) (1.9 MB)
Part 2 (PDF) (1.5 MB) -
Chemistry Review(s) & Environmental Assessment (PDF) (2 MB)
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Pharmacology Review(s) (PDF) (2.3 MB)
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Statistical Review(s), Microbiology Review(s), & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2 MB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (2.2 MB)
Part 2 (PDF) (2 MB)
Date created: September 10, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.