Acetaminophen / Oxycodone Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
1995-07-03
License(s)
ANDA
RxNORM
ORAL CAPSULE\ACETAMINOPHEN:OXYCODONE
FDAOB
ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, GELATIN COATED\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\ACETAMINOPHEN: OXYCODONE
ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000542795ANDARoxane Laboratories, Inc1995-07-03ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALCAPSULEANDA04006161b0c7d6-21ff-4a07-b737-1edd105bb74d
2004060532ANDAMallinckrodt, Inc.2009-07-072017-08-31ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDANDA0402573bfe9f12-5af5-404e-9ba5-98ed8d7d644d
3005550658ANDABarr Laboratories Inc.1999-05-202016-02-29ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALCAPSULEANDA04028928e157c7-6b3b-4dc2-adf3-e6c212515118
4005910737ANDAWatson Laboratories, Inc.1997-10-30ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALCAPSULEANDA040234a1df89be-8dbe-465b-9d52-a4e767ab7dc3

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040061ROXILOXTrueROXANE LABORATORIES INC1995-07-03ANDA040061_001Fluphenazine Oral Solution
2ANDA040106OXYCODONE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-07-30ANDA040106_001Fluphenazine Oral Solution
3ANDA040199OXYCODONE AND ACETAMINOPHENTrueACTAVIS ELIZABETH LLC1998-12-30ANDA040199_001Fluphenazine Oral Solution
4ANDA040219OXYCODONE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1998-01-22ANDA040219_001Fluphenazine Oral Solution
5ANDA040234OXYCODONE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1997-10-30ANDA040234_001Fluphenazine Oral Solution
6ANDA040257OXYCODONE AND ACETAMINOPHENTrueMALLINCKRODT CHEMICAL INC1998-08-04ANDA040257_001Fluphenazine Oral Solution
7ANDA040289OXYCODONE AND ACETAMINOPHENTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-03-16ANDA040289_001Fluphenazine Oral Solution
8ANDA040303OXYCODONE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS LLC1999-12-30ANDA040303_001Fluphenazine Oral Solution
9ANDA040304OXYCODONE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-10-02ANDA040304_001Fluphenazine Oral Solution
10ANDA088246TYLOX-325TrueORTHO MCNEIL PHARMACEUTICAL INC1984-11-08ANDA088246_001Fluphenazine Oral Solution
11ANDA088790TYLOXTrueJANSSEN PHARMACEUTICALS INC1984-12-12ANDA088790_001Fluphenazine Oral Solution
12ANDA089994OXYCODONE AND ACETAMINOPHENTrueHALSEY DRUG CO INC1989-05-04ANDA089994_001Fluphenazine Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040061_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1995-07-03ROXILOX
2ANDA040106_001discontinuedACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalse1996-07-30OXYCODONE AND ACETAMINOPHEN
3ANDA040199_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1998-12-30OXYCODONE AND ACETAMINOPHEN
4ANDA040219_001discontinuedACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalse1998-01-22OXYCODONE AND ACETAMINOPHEN
5ANDA040234_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1997-10-30OXYCODONE AND ACETAMINOPHEN
6ANDA040257_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1998-08-04OXYCODONE AND ACETAMINOPHEN
7ANDA040289_001discontinuedACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalse1999-03-16OXYCODONE AND ACETAMINOPHEN
8ANDA040303_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1999-12-30OXYCODONE AND ACETAMINOPHEN
9ANDA040304_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse2000-10-02OXYCODONE AND ACETAMINOPHEN
10ANDA088246_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (325MG)ORALCAPSULEFalse1984-11-08TYLOX-325
11ANDA088790_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1984-12-12TYLOX
12ANDA089994_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1989-05-04OXYCODONE AND ACETAMINOPHEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
128e157c7-6b3b-4dc2-adf3-e6c212515118 (view SPL)OXYCODONE AND ACETAMINOPHEN CAPSULES USP CIIprescriptionHuman PrescriptionBarr Laboratories Inc.2014-07-086005550658
23bfe9f12-5af5-404e-9ba5-98ed8d7d644d (view SPL)OXYCODONE AND ACETAMINOPHENCAPSULES USP5 mg/500 mg CII Rx only Analgesic For Oral UseprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-2611004060532
361b0c7d6-21ff-4a07-b737-1edd105bb74d (view SPL)OXYCODONE and ACETAMINOPHEN Capsules USP CIIprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-08-059000542795
4a1df89be-8dbe-465b-9d52-a4e767ab7dc3 (view SPL)Oxycodone and Acetaminophen Capsules USPCII Revised: August 2013 Rx only 173228-2prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-08-136005910737

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