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Last Updated: December 3, 2022

Details for New Drug Application (NDA): 204031


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NDA 204031 describes XARTEMIS XR, which is a drug marketed by Mallinckrodt Inc and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XARTEMIS XR profile page.

The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 204031
Tradename:XARTEMIS XR
Applicant:Mallinckrodt Inc
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:12

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength325MG;7.5MG
Approval Date:Mar 11, 2014TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jun 1, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
Patent:See Plans and PricingPatent Expiration:Mar 11, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Patent:See Plans and PricingPatent Expiration:Nov 19, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

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