Drug Approval Package

 Zerit XR (Stavudine) Extended-Release Capsules
Company:  Bristol-Myers Squibb Company
Application No.:  021453
Approval Date: 12/31/2002

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: June 082006

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