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Xartemis XR Approval History

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

Marketing Status: Discontinued

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

DateArticle
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)

Further information

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