Aspirin / Oxycodone Oral Tablet

Brand(s)
Endodan Reformulated May 2009
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mayne Pharma Inc. (2015-05-08)
Oldest Current Product
1994-05-20
License(s)
NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\ASPIRIN:OXYCODONE
FDAOB
ORAL\TABLET\ASPIRIN: OXYCODONE HYDROCHLORIDE
ORAL\TABLET\ASPIRIN: OXYCODONE HYDROCHLORIDE: OXYCODONE TEREPHTHALATE
SPL Active
ORAL\TABLET\ASPIRIN: OXYCODONE HYDROCHLORIDE
ORAL\TABLET\ASPIRIN: OXYCODONE HYDROCHLORIDE: OXYCODONE TEREPHTHALATE
SPL Moiety
ORAL\TABLET\ASPIRIN: OXYCODONE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682094ANDAPhysicians Total Care, Inc.1998-02-27ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATEORALTABLET005910820ANDA040255946b4df5-f1dc-42a7-acb9-1d2543c9bb44

aspirin 325 mg / oxycodone hydrochloride 4.84 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786117ANDAMylan Pharmaceuticals Inc.2011-05-02ASPIRIN, OXYCODONE HYDROCHLORIDEORALTABLETANDA091670b82495ce-8d77-4e12-a064-274a88448ba3
2005913551ANDAWatson Laboratories, Inc.2011-10-18ASPIRIN, OXYCODONE HYDROCHLORIDEORALTABLETANDA090084a598f735-d2e2-43ad-be77-8627ea4a9b78
3683080845ANDAMayne Pharma Inc.2011-05-02ASPIRIN, OXYCODONE HYDROCHLORIDEORALTABLETANDA0916703848642e-cc9e-4150-8199-281b294c18bc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900947Endodan Reformulated May 2009NDA AUTHORIZED GENERICStat Rx Usa Llc1994-05-20ASPIRIN, OXYCODONE HYDROCHLORIDEORALTABLET609510310NDA00733723a60947-6058-4bf7-a3ee-ae396e55d939

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040255OXYCODONE AND ASPIRINTrueWATSON LABORATORIES INC1998-02-27ANDA040255_001
2ANDA040260OXYCODONE AND ASPIRINTrueMUTUAL PHARMACEUTICAL CO INC1998-07-17ANDA040260_001
3ANDA087464CODOXYTrueHALSEY DRUG CO INC1982-07-01ANDA087464_001
4ANDA087742OXYCODONE AND ASPIRIN (HALF-STRENGTH)TrueROXANE LABORATORIES INC1982-06-04ANDA087742_001
5ANDA087743ROXIPRINTrueROXANE LABORATORIES INC1982-06-04ANDA087743_001
6ANDA087794OXYCODONE AND ASPIRINTrueMUTUAL PHARMACEUTICAL CO INC1982-05-26ANDA087794_001
7ANDA090084OXYCODONE AND ASPIRINACTAVIS LABORATORIES FL INC2011-03-22ANDA090084_001
8ANDA091670OXYCODONE AND ASPIRINCOASTAL PHARMACEUTICALS2011-03-16ANDA091670_001
9NDA007337PERCODANENDO PHARMACEUTICALS INCNDA007337_005, NDA007337_006, NDA007337_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040255_001discontinuedOXYCODONE HYDROCHLORIDE (4.5MG), ASPIRIN (325MG), OXYCODONE TEREPHTHALATE (0.38MG)ORALTABLETFalse1998-02-27OXYCODONE AND ASPIRIN
2ANDA040260_001discontinuedASPIRIN (325MG), OXYCODONE TEREPHTHALATE (0.38MG), OXYCODONE HYDROCHLORIDE (4.5MG)ORALTABLETFalse1998-07-17OXYCODONE AND ASPIRIN
3ANDA087464_001discontinuedASPIRIN (325MG), OXYCODONE HYDROCHLORIDE (4.5MG), OXYCODONE TEREPHTHALATE (0.38MG)ORALTABLETFalse1982-07-01CODOXY
4ANDA087742_001discontinuedASPIRIN (325MG), OXYCODONE HYDROCHLORIDE (2.25MG), OXYCODONE TEREPHTHALATE (0.19MG)ORALTABLETFalse1982-06-04OXYCODONE AND ASPIRIN (HALF-STRENGTH)
5ANDA087743_001discontinuedASPIRIN (325MG), OXYCODONE TEREPHTHALATE (0.38MG), OXYCODONE HYDROCHLORIDE (4.5MG)ORALTABLETFalse1982-06-04ROXIPRIN
6ANDA087794_001discontinuedASPIRIN (325MG), OXYCODONE HYDROCHLORIDE (4.5MG), OXYCODONE TEREPHTHALATE (0.38MG)ORALTABLETFalse1982-05-26OXYCODONE AND ASPIRIN
7ANDA090084_001RXASPIRIN (325MG), OXYCODONE HYDROCHLORIDE (4.8355MG)ORALTABLETFalseAA2011-03-22OXYCODONE AND ASPIRIN
8ANDA091670_001RXASPIRIN (325MG), OXYCODONE HYDROCHLORIDE (4.8355MG)ORALTABLETFalseAA2011-03-16OXYCODONE AND ASPIRIN
9NDA007337_005discontinuedASPIRIN (325MG), OXYCODONE TEREPHTHALATE (0.19MG), OXYCODONE HYDROCHLORIDE (2.25MG)ORALTABLETFalsePERCODAN
10NDA007337_006discontinuedASPIRIN (325MG), OXYCODONE TEREPHTHALATE (0.38MG), OXYCODONE HYDROCHLORIDE (4.5MG)ORALTABLETFalsePERCODAN
11NDA007337_007RXASPIRIN (325MG), OXYCODONE HYDROCHLORIDE (4.8355MG)ORALTABLETTrueAA2005-08-05PERCODAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
123a60947-6058-4bf7-a3ee-ae396e55d939 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-05-231165900947
23848642e-cc9e-4150-8199-281b294c18bc (view SPL)OXYCODONE AND ASPIRIN TABLETS, USP CII4.8355 mg/325 mgprescriptionHuman PrescriptionMayne Pharma Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-05-081683080845
3946b4df5-f1dc-42a7-acb9-1d2543c9bb44 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-08-291548682094
4a598f735-d2e2-43ad-be77-8627ea4a9b78 (view SPL)Oxycodone and AspirinprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-10-253005913551
5b82495ce-8d77-4e12-a064-274a88448ba3 (view SPL)OXYCODONE AND ASPIRIN TABLETS, USP CII4.8355 mg/325 mgprescriptionHuman PrescriptionMylan Pharmaceuticals Inc.MANUFACTURE2011-03-213003786117

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