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Xartemis XR Approval History

  • FDA approved: Yes (First approved March 11th, 2014)
  • Brand name: Xartemis XR
  • Generic name: acetaminophen and oxycodone hydrochloride
  • Dosage form: Extended-Release Tablets
  • Previous name: MNK-795
  • Company: Mallinckrodt Inc.
  • Treatment for: Pain

Xartemis XR (acetaminophen and oxycodone hydrochloride) is an extended-release analgesic and opioid agonist formulation for the management of moderate to severe acute pain.

Development History and FDA Approval Process for Xartemis XR

Mar 12, 2014Approval FDA Approves Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
Nov 25, 2013FDA Extends Review of Mallinckrodt’s NDA for Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)

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