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Oxecta Approval History

  • FDA approved: Yes (First approved June 17th, 2011)
  • Brand name: Oxecta
  • Generic name: oxycodone
  • Dosage form: Tablets
  • Previous name: Acurox
  • Company: Pfizer Inc. and Acura Pharmaceuticals Inc.
  • Treatment for: Pain

Oxecta (oxycodone hydrochloride) is an abuse-deterrent opioid analgesic formulation for the relief of moderate to severe pain.

Development History and FDA Approval Process for Oxecta

DateArticle
Jun 20, 2011Approval Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII
Dec 20, 2010King Pharmaceuticals and Acura Pharmaceuticals Announce Submission of New Drug Application for Acurox Tablets
May  4, 2010King Pharmaceuticals and Acura Pharmaceuticals Announce Plans to Submit an NDA for Acurox Tablets without Niacin
Apr 23, 2010Acura Pharmaceuticals and King Pharmaceuticals Provide Update on FDA Advisory Committee Meeting For Acurox
Sep  3, 2009Acura Pharmaceuticals and King Pharmaceuticals Provide Update on Acurox NDA
Jul  2, 2009Acura and King Receive FDA Complete Response Letter Regarding Acurox
Mar  3, 2009Acurox Tablets New Drug Application Accepted for Filing With a Priority Review Classification
Jan  2, 2009New Drug Application Submitted For Acurox Tablets

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