Drug Approval Package
PREMPRO (conjugated
estrogens
/medroxyprogesterone acetate tablets) and PREMPHASE (conjugated
estrogens/medroxyprogesterone acetate
tablets).
Company: Wyeth Pharmaceuticals
Application No.: 020527-S17
Approval Date: 3/12/2003
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Administrative Document(s) & Correspondence (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: September 11, 2003
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