Drug Approval Package

Celexa Tablets (Citalopram Hydrobromide)
Company:  Forest Laboratories, Inc.
Application No.:  20-822
Approval Date: 7/17/1998

• Approval Letter & Printed Labeling (PDF) (3 MB)

• 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)

• Pharmacology Review(s) (PDF)
  Part 1 (2.7 MB)
  Part 2 (3 MB)

• 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)

• 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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