Drug Approval Package
Rocicodone (Oxycodone Hydrochloride) Sustained Release Tablets
Company: Roxane Laboratories, Inc.
Application No.: 20-932
Approval Date: 10/26/1998
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Approval Letter (PDF) (155 KB)
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Chemistry Review(s), Pharmacology Review(s) & Statistical Review(s) (PDF) (1.3 MB)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (1.6 MB)
Part 2 (PDF) (1.6 MB) -
Administrative Document(s)/Correspondence (PDF) (1.7 MB)
Date created: March 30, 2001; last update: July 5, 2005
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