Drug Approval Package

 Prometrium (Progesterone) Capsules
Company:  Schering Corporation
Application No.:  020843
Approval Date: 12/26/1998

• Approval Letter(s) (PDF)    

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)    

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) (PDF)    

• Correspondence (PDF)  

Date created: June 16, 2005

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