Drug Approval Package

Ditropan XL ( Oxybutinin Chloride) Tablets
Company:  Alza Corporation
Application No.:  20-897
Approval Date: 12/16/1998

• Approval Letter & Medical Review(s) (PDF) (2.8 MB)

• Chemistry Review(s), Pharmacology Review(s)  & Statistical Review(s) (PDF) (2.6 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Document(s)/Correspondence (PDF) (2.1 MB)

Date created: March 30, 2001; last update: July 5, 2005

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