Drug Approval Package
Prempro
(conjugated estrogens/medroxyprogesterone acetate) Tablets
Company: Wyeth-Ayerst Laboratories
Application No.: 20-527/SE2-006
Approval Date: 1/9/1998
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Approval Letter(s) (PDF) (617 KB)
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Medical Review(s) (PDF) (2.4 MB)
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Pharmacology Review(s), Statistical Review(s), & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.9 MB)
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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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