Drug Approval Package
Celexa Tablets (Citalopram Hydrobromide)
Company: Forest Laboratories, Inc.
Application No.: 20-822
Approval Date: 7/17/1998
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Approval Letter & Printed Labeling (PDF) (3 MB)
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Medical Review(s) (PDF)
Part 1 (3.1 MB)
Part 2 (3.3 MB)
Part 3 (3 MB)
Part 4 (2.6 MB)
Part 5 (3.2 MB)
Part 6 (2.8 MB) -
Chemistry Review(s) (PDF) (192 KB)
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Statistical Review(s) (PDF)
Part 1 (2.2 MB)
Part 2 (2.4 MB)
Part 3 (2.5 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.4 MB)
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Administrative Document(s)/Correspondence (PDF)
Part 1 (3.6 MB)
Part 2 (3.7 MB)
Part 3 (3 MB)
Part 4 (2.8 MB)
Date created: March 30, 2001; last updated: July 1, 2005
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