Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English