Drug Approval Package

 Estrogel (Estradiol) Gel
Company:  Solvay Pharmaceuticals
Application No.:  021166
Approval Date: 2/9/2004

• 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) (PDF)

• Correspondence (PDF)  

Date created: June 232005

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