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-six 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:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 11, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 1, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
Patent:	⤷ Sign Up	Patent Expiration:	Mar 11, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Patent:	⤷ Sign Up	Patent Expiration:	Nov 19, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Expired US Patents for NDA 204031

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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