Drug Approval Package

Prempro (conjugated estrogens/medroxyprogesterone acetate) Tablets
Company:  Wyeth-Ayerst Laboratories
Application No.:  20-527/SE2-006
Approval Date: 1/9/1998

• Approval Letter(s) (PDF) (617 KB)

• Medical Review(s) (PDF) (2.4 MB)

• Pharmacology Review(s), Statistical Review(s), & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.9 MB)

• Administrative Document(s)
  Part 1 (PDF) (2.5 MB)
  Part 2 (PDF) (3 MB)

• Correspondence (PDF) (2 MB)

Date created: September 10, 2001

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