Drug Approval Package

Activelle (Estradiol/Norethindrone Acetate Tablets)
Company:  Novo Nordisk Pharmaceuticals
Application No.:  20-907
Approval Date: 11/18/1998

• Approval Letter & Medical Review(s) (PDF) (2.3 MB)

• Chemistry Review(s), Pharmacology Review(s), Statistical Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.3 MB)

• Administrative Document(s)/Correspondence (PDF) (1.4 MB)

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

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