Drug Approval Package
Opana (Oxymorphone Hydrochloride) Extended-Release Tablets
Company: Endo Pharmaceuticals
Application No.: 021610 & 021611
Approval Date: 06/22/2006
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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)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF)
Part 8 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: October 3, 2008
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