Drug Approval Package
Ortho-Prefest (17B-Estradiol Nd
17B-Estradiol/Norgestimate) Tablets
Company: R.W. Johnson Pharmaceutical Research Institute
Application No.: 021040
Approval Date: 10/22/1999
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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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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Correspondence (PDF)
Date created: August 2, 2005
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