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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. It is available from two suppliers. 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-five drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for NDA: 204031

Mallinckrodt Inc
acetaminophen; oxycodone hydrochloride

Pharmacology for NDA: 204031

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 204031

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 204031 NDA Mallinckrodt, Inc 23635-115 23635-115-01 100 TABLET, COATED in 1 BOTTLE (23635-115-01)
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 204031 NDA Mallinckrodt, Inc 23635-115 23635-115-62 10 BLISTER PACK in 1 CARTON (23635-115-62) > 10 TABLET, COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength325MG;7.5MG
Approval Date:Mar 11, 2014TE:RLD:Yes
Patent:6,488,962Patent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,394,408Patent Expiration:Mar 11, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:8,597,681Patent Expiration:Dec 21, 2030Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.