Acetaminophen / Oxycodone Extended Release Oral Tablet

Brand(s)
Xartemis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt, Inc (2015-03-31)
Oldest Current Product
2013-04-30
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\ACETAMINOPHEN:OXYCODONE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\ACETAMINOPHEN: OXYCODONE

product(s) by strength(s)

12 hr acetaminophen 325 mg / oxycodone hydrochloride 7.5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1236350115XartemisNDAMallinckrodt, Inc2013-04-30ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALTABLET, COATEDNDA204031efcb1e8b-c0be-47ee-b09e-7a6b41e64bdd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630531XartemisNDAPd-Rx Pharmaceuticals, Inc.2013-04-30ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALTABLET, COATED236350115NDA2040316beb5fe9-ff58-4fa6-bd69-7790412bdb06

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204031XARTEMIS XRMALLINCKRODT INC2014-03-11p8394408, SUBSTANCE
p8992975, SUBSTANCE
p8597681, SUBSTANCE
p8372432, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA, SUBSTANCE
p7976870, METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
p8741885, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA, SUBSTANCE
p8658631, SUBSTANCE
p8668929, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
p8980319, SUBSTANCE
p8377453, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA, SUBSTANCE
p9050335, SUBSTANCE
p6488962, SUBSTANCE
NEW PRODUCT [2017-03-11]NDA204031_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204031_001RXOXYCODONE HYDROCHLORIDE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLET, EXTENDED RELEASETrue2014-03-11XARTEMIS XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6488962 (view patent)2020-06-20NDA204031, NDA021744, NDA021748, NDA022544Ciprofloxacin Extended Release Oral Tablet
gabapentin Oral Tablet
Metformin Extended Release Oral Tablet
gabapentin Oral Capsule
2p7976870 (view patent)2027-06-01NDA204031
3p8372432 (view patent)2029-03-11NDA204031
4p8377453 (view patent)2029-11-19NDA204031
5p8394408 (view patent)2029-03-11NDA204031
6p8597681 (view patent)2030-12-21NDA204031
7p8658631 (view patent)2032-05-16NDA204031
8p8668929 (view patent)2029-03-11NDA204031
9p8741885 (view patent)2032-05-16NDA204031
10p8980319 (view patent)2030-12-21NDA204031
11p8992975 (view patent)2032-05-16NDA204031
12p9050335 (view patent)2032-05-16NDA204031

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16beb5fe9-ff58-4fa6-bd69-7790412bdb06 (view SPL)These highlights do not include all the information needed to use XARTEMISXR safely and effectively. See full prescribing information for XARTEMISXR. XARTEMISXR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets, for oral use,CII Initial U.S. Approval: 1976prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-03-123430630531
2efcb1e8b-c0be-47ee-b09e-7a6b41e64bdd (view SPL)These highlights do not include all the information needed to use XARTEMISXR safely and effectively. See full prescribing information for XARTEMISXR. XARTEMISXR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets, for oral use,CII Initial U.S. Approval: 1976prescriptionHuman PrescriptionMallinckrodt, Inc2015-03-319236350115

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII