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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204031

XARTEMIS XR (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG;7.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: XARTEMIS XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204031
Product Number: 001
Approval Date: Mar 11, 2014
Applicant Holder Full Name: MALLINCKRODT INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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