Drug Approval Package

Prometrium/progesterone USP Capsules, 100 mg
Company:  Schering-Plough Research Institute
Application No.:  19781
Approval Date: 5/14/1998

• Approval Letter (PDF)

• Label (PDF)

• Medical Review (PDF)

• Chemistry, Environmental Assessment, Pharmacology Reviews (PDF)

• Clinical Pharmacology and Biopharmaceutics Reviews (PDF)

• Administrative Documents (PDF)

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

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