Drug Approval Package
Ortho
EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System)
Company: R.W. Johnson Pharmaceutical Research Institute
Application No.: 21-180
Approval Date: 11/20/01
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Approval Letter(s) (PDF)
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Printed Labeling (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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Microbiology Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: November 20, 2001
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