Drug Approval Package
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Ortho Tri-Cyclen (Norgestimate/Ethinyl Estradiol Tablets
Company: Ortho-McNeil Pharmaceutical, Inc.
Application No.: 021690
Approval Date: 05/13/2005
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Approval Letter(s) (PDF)
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Approvable Letter (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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Statistical Review(s) (PDF)
Date created: August 22, 2007
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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