Oxacillin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-01-06)
Oldest Current Product
1976-01-06
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\OXACILLIN
FDAOB
INJECTION\INJECTION\OXACILLIN SODIUM\rdfq
INTRAVENOUS\POWDER\OXACILLIN SODIUM
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\OXACILLIN SODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\OXACILLIN SODIUM
INTRAVENOUS\INJECTION, SOLUTION\OXACILLIN SODIUM
INTRAVENOUS\POWDER, FOR SOLUTION\OXACILLIN SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\OXACILLIN
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\OXACILLIN
INTRAVENOUS\INJECTION, SOLUTION\OXACILLIN
INTRAVENOUS\POWDER, FOR SOLUTION\OXACILLIN

product(s) by strength(s)

oxacillin 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813103ANDASandoz Inc1991-05-09OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0614909148232b-328d-401a-bb74-d0e7360e3ada
2007819113ANDASandoz Inc1991-05-09OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA061490962b1fb2-86fe-4ee1-afdf-5956b1891403
3250210163ANDASagent Pharmaceuticals2012-06-01, 2014-06-15OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0912457cbca4b7-0c02-4367-9e93-04ee8db47f9d, 9f0f30cb-ade2-4690-b63d-b069b8e4ed89
4551500129ANDAAuromedics Pharma Llc2013-01-18OXACILLIN SODIUMINTRAVENOUSPOWDER, FOR SOLUTIONANDA201538152758c0-d225-4761-abeb-3f1cb0190806, b0a443a8-05d2-44bc-a150-58526b7f05f6

oxacillin 167 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007039106ANDATeva Parenteral Medicines, Inc2014-08-26OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA091486b735ce95-f6e6-45cc-b5a4-56e80af15e56
2007039107ANDATeva Parenteral Medicines, Inc2014-08-26OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA091486b735ce95-f6e6-45cc-b5a4-56e80af15e56
3007813095ANDASandoz Inc1986-12-23OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0627370a439e9c-2777-4942-94aa-41a54a6da92e
4007813099ANDASandoz Inc1976-01-06OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06149081f25efc-fb1d-40d6-bd55-c72753c32459
5007813101ANDASandoz Inc1976-01-06OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06149081f25efc-fb1d-40d6-bd55-c72753c32459
6007819109ANDASandoz Inc1976-01-06OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06149039453441-db41-4979-9896-51b5eebb5f31
7007819111ANDASandoz Inc1976-01-06OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06149039453441-db41-4979-9896-51b5eebb5f31
8007819112ANDASandoz Inc1986-12-23OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062737de254786-b20e-4739-9c50-e640400b50a7
9250210146ANDASagent Pharmaceuticals2012-06-01, 2014-06-15OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0912465d90bedc-ce45-4da6-be11-0dbf0b220f03, f3bee4d7-82d8-4e2d-8fc8-4446e6fbf999
10250210162ANDASagent Pharmaceuticals2012-06-01, 2014-06-15OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0912465d90bedc-ce45-4da6-be11-0dbf0b220f03, f3bee4d7-82d8-4e2d-8fc8-4446e6fbf999
11551500127ANDAAuromedics Pharma Llc2013-01-18OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA20153981e90279-9889-47bd-974b-334c181f295c
12551500128ANDAAuromedics Pharma Llc2013-01-18OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA201539110b0fd1-c842-4bab-81eb-4b1d58a746af, 81e90279-9889-47bd-974b-334c181f295c
13761260100ANDAAgila Specialties Private Limited2014-08-26OXACILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0914869b4b9e04-30a9-4fa5-b38d-3a6dea8c66be

oxacillin 20 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381013NDABaxter Healthcare Corporation1989-10-26OXACILLIN SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA050640d893e45b-7f18-4c67-b10c-1e2e52a6b3ef

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813094ANDASandoz Inc1986-12-23OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0627370a439e9c-2777-4942-94aa-41a54a6da92e
2007819110ANDASandoz Inc1986-12-23OXACILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062737de254786-b20e-4739-9c50-e640400b50a7

oxacillin 40 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381015NDABaxter Healthcare Corporation1989-10-26OXACILLIN SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA050640d893e45b-7f18-4c67-b10c-1e2e52a6b3ef

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061334BACTOCILLTrueGLAXOSMITHKLINEANDA061334_006, ANDA061334_007, ANDA061334_008, ANDA061334_009, ANDA061334_010
2ANDA061490OXACILLIN SODIUMSANDOZ INCANDA061490_001, ANDA061490_002, ANDA061490_003, ANDA061490_004, ANDA061490_006
3ANDA062711OXACILLIN SODIUMTrueELKINS SINN DIV AH ROBINS CO INC1989-02-03ANDA062711_001, ANDA062711_002, ANDA062711_003, ANDA062711_004, ANDA062711_005, ANDA062711_006
4ANDA062736BACTOCILLTrueGLAXOSMITHKLINE1986-12-19ANDA062736_001, ANDA062736_002
5ANDA062737OXACILLIN SODIUMSANDOZ INC1986-12-23ANDA062737_001, ANDA062737_002
6ANDA062798OXACILLIN SODIUMTrueISTITUTO BIOCHIMICO ITALIANO SPA1995-12-11ANDA062798_001, ANDA062798_002, ANDA062798_003, ANDA062798_004, ANDA062798_005
7ANDA062856OXACILLIN SODIUMTrueWATSON LABORATORIES INC1988-10-26ANDA062856_001, ANDA062856_002, ANDA062856_003, ANDA062856_004, ANDA062856_005
8ANDA062984OXACILLIN SODIUMTrueWATSON LABORATORIES INC1988-09-29ANDA062984_001
9ANDA091245OXACILLIN SODIUMSAGENT PHARMACEUTICALS INC2012-03-30ANDA091245_001
10ANDA091246OXACILLIN SODIUMSAGENT PHARMACEUTICALS INC2012-03-30ANDA091246_001, ANDA091246_002
11ANDA091486OXACILLIN SODIUMMYLAN LABORATORIES LTD2014-08-25ANDA091486_001, ANDA091486_002
12ANDA201538OXACILLIN SODIUMAUROBINDO PHARMA LTD2013-01-18ANDA201538_001
13ANDA201539OXACILLIN SODIUMAUROBINDO PHARMA LTD2013-01-18ANDA201539_001, ANDA201539_002
14NDA050195OXACILLIN SODIUMTrueAPOTHECON SUB BRISTOL MYERS SQUIBB CONDA050195_001, NDA050195_002, NDA050195_003, NDA050195_004, NDA050195_005
15NDA050640BACTOCILL IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1989-10-26NDA050640_001, NDA050640_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA061334_006discontinuedOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1982-03-26BACTOCILL
2ANDA061334_007discontinuedOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1982-03-26BACTOCILL
3ANDA061334_008discontinuedOXACILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalse1982-03-26BACTOCILL
4ANDA061334_009discontinuedOXACILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1982-03-26BACTOCILL
5ANDA061334_010discontinuedOXACILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseBACTOCILL
6ANDA061490_001discontinuedOXACILLIN SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
7ANDA061490_002discontinuedOXACILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
8ANDA061490_003RXOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAPOXACILLIN SODIUM
9ANDA061490_004RXOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAPOXACILLIN SODIUM
10ANDA061490_006RXOXACILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP1991-05-09OXACILLIN SODIUM
11ANDA062711_001discontinuedOXACILLIN SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1989-02-03OXACILLIN SODIUM
12ANDA062711_002discontinuedOXACILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1989-02-03OXACILLIN SODIUM
13ANDA062711_003discontinuedOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1989-02-03OXACILLIN SODIUM
14ANDA062711_004discontinuedOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1989-02-03OXACILLIN SODIUM
15ANDA062711_005discontinuedOXACILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalse1989-02-03OXACILLIN SODIUM
16ANDA062711_006discontinuedOXACILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse1989-02-03OXACILLIN SODIUM
17ANDA062736_001discontinuedOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1986-12-19BACTOCILL
18ANDA062736_002discontinuedOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1986-12-19BACTOCILL
19ANDA062737_001RXOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INTRAVENOUSPOWDERTrueAP1986-12-23OXACILLIN SODIUM
20ANDA062737_002RXOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INTRAVENOUSPOWDERTrueAP1986-12-23OXACILLIN SODIUM
21ANDA062798_001discontinuedOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1995-12-11OXACILLIN SODIUM
22ANDA062798_002discontinuedOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1995-12-11OXACILLIN SODIUM
23ANDA062798_003discontinuedOXACILLIN SODIUM (EQ 125MG BASE/VIAL)INJECTIONFalse1995-12-11OXACILLIN SODIUM
24ANDA062798_004discontinuedOXACILLIN SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1995-12-11OXACILLIN SODIUM
25ANDA062798_005discontinuedOXACILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1995-12-11OXACILLIN SODIUM
26ANDA062856_001discontinuedOXACILLIN SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1988-10-26OXACILLIN SODIUM
27ANDA062856_002discontinuedOXACILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1988-10-26OXACILLIN SODIUM
28ANDA062856_003discontinuedOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1988-10-26OXACILLIN SODIUM
29ANDA062856_004discontinuedOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1988-10-26OXACILLIN SODIUM
30ANDA062856_005discontinuedOXACILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalse1988-10-26OXACILLIN SODIUM
31ANDA062984_001discontinuedOXACILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse1988-09-29OXACILLIN SODIUM
32ANDA091245_001RXOXACILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2012-03-30OXACILLIN SODIUM
33ANDA091246_001RXOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-03-30OXACILLIN SODIUM
34ANDA091246_002RXOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-03-30OXACILLIN SODIUM
35ANDA091486_001RXOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2014-08-25OXACILLIN SODIUM
36ANDA091486_002RXOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2014-08-25OXACILLIN SODIUM
37ANDA201538_001RXOXACILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2013-01-18OXACILLIN SODIUM
38ANDA201539_001RXOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2013-01-18OXACILLIN SODIUM
39ANDA201539_002RXOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2013-01-18OXACILLIN SODIUM
40NDA050195_001discontinuedOXACILLIN SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
41NDA050195_002discontinuedOXACILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
42NDA050195_003discontinuedOXACILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
43NDA050195_004discontinuedOXACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
44NDA050195_005discontinuedOXACILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseOXACILLIN SODIUM
45NDA050640_001RXOXACILLIN SODIUM (EQ 20MG BASE/ML)INJECTIONTrue1989-10-26BACTOCILL IN PLASTIC CONTAINER
46NDA050640_002RXOXACILLIN SODIUM (EQ 40MG BASE/ML)INJECTIONTrue1989-10-26BACTOCILL IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10a439e9c-2777-4942-94aa-41a54a6da92e (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-03-0311007813094, 007813095
2110b0fd1-c842-4bab-81eb-4b1d58a746af (view SPL)OXACILLIN FOR INJECTION, USPRx onlyprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-251551500128
3152758c0-d225-4761-abeb-3f1cb0190806 (view SPL)OXACILLIN FOR INJECTION, USPprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-02-125551500129
439453441-db41-4979-9896-51b5eebb5f31 (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-09-3014007819109, 007819111
55d90bedc-ce45-4da6-be11-0dbf0b220f03 (view SPL)Oxacillin for Injection, USP(For IV or IM Injection)prescriptionHuman PrescriptionSagent Pharmaceuticals2013-08-012250210146, 250210162
67cbca4b7-0c02-4367-9e93-04ee8db47f9d (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2013-08-012250210163
781e90279-9889-47bd-974b-334c181f295c (view SPL)OXACILLIN FOR INJECTION, USPRx onlyprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-02-104551500127, 551500128
881f25efc-fb1d-40d6-bd55-c72753c32459 (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-09-3014007813099, 007813101
99148232b-328d-401a-bb74-d0e7360e3ada (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-09-3013007813103
10962b1fb2-86fe-4ee1-afdf-5956b1891403 (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-09-3014007819113
119b4b9e04-30a9-4fa5-b38d-3a6dea8c66be (view SPL)Oxacillin for Injection, USP For Intramuscular or Intravenous Injection Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection and other antibacterial drugs, oxacillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionAgila Specialties Private LimitedAnalysis, Manufacture, Pack, Sterilize2014-08-272761260100
129f0f30cb-ade2-4690-b63d-b069b8e4ed89 (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2015-10-137250210163
13b0a443a8-05d2-44bc-a150-58526b7f05f6 (view SPL)OXACILLIN FOR INJECTION, USPprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-04-221551500129
14b735ce95-f6e6-45cc-b5a4-56e80af15e56 (view SPL)Oxacillin for Injection, USP For Intramuscular or Intravenous Injection Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection and other antibacterial drugs, oxacillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionTeva Parenteral Medicines, IncANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-281007039106, 007039107
15d893e45b-7f18-4c67-b10c-1e2e52a6b3ef (view SPL)Oxacillin Injection, USP in Plastic Container For Intravenous Use Only GALAXY Container (PL 2040)prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-068003381013, 003381015
16de254786-b20e-4739-9c50-e640400b50a7 (view SPL)Oxacillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-03-0311007819110, 007819112
17f3bee4d7-82d8-4e2d-8fc8-4446e6fbf999 (view SPL)Oxacillin for Injection, USP(For Intravenous or Intramuscular Injection)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-10-137250210146, 250210162

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