Piperacillin / tazobactam Injectable Solution

Brand(s)
Zosyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wyeth Pharmaceuticals, Inc. (2015-10-28)
Oldest Current Product
1993-11-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\PIPERACILLIN:TAZOBACTAM
FDAOB
INJECTION\INJECTION\PIPERACILLIN SODIUM: TAZOBACTAM SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PIPERACILLIN SODIUM: TAZOBACTAM SODIUM
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PIPERACILLIN SODIUM: TAZOBACTAM SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PIPERACILLIN ANHYDROUS: TAZOBACTAM
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PIPERACILLIN ANHYDROUS: TAZOBACTAM

product(s) by strength(s)

piperacillin 200 mg/ml / tazobactam 25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002065501ZosynNDAWyeth Pharmaceuticals, Inc.2013-06-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA05068481b0bb45-ce9d-43e7-b181-64315e14be55, c08f0339-d24b-43c1-931b-77a36b120dfa
2002068859ZosynNDAWyeth Pharmaceuticals, Inc.1993-11-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA050684e103a5e4-1d0b-4e1f-c69b-774f6ab70df1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1445670804ANDAWg Critical Care, Llc2009-10-20PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA09049817a400ae-cbaa-4d07-95f4-c6917dfc0585
2605050773ANDAApotex Corp2009-10-05PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0654467b3ba6b9-59e1-454a-9ddc-ab3592221627
3633230304ANDAApp Pharmaceuticals, Llc2011-05-31PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0904982cfa6723-175b-4c4d-8212-266844b07610, c78e0931-ec79-58e5-8658-7fe692dc3b8b, e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA065362PIPERACILLIN AND TAZOBACTAMSANDOZ INC2010-10-21ANDA065362_001, ANDA065362_002, ANDA065362_003Piperacillin / tazobactam Injection
2ANDA065363PIPERACILLIN AND TAZOBACTAMSANDOZ INC2010-10-21ANDA065363_001, ANDA065363_002, ANDA065363_003Piperacillin / tazobactam Injection
3ANDA065386PIPERACILLIN AND TAZOBACTAMHOSPIRA INC2009-09-15ANDA065386_001, ANDA065386_002, ANDA065386_003Piperacillin / tazobactam Injection
4ANDA065446PIPERACILLIN AND TAZOBACTAMHOSPIRA INC2009-09-15ANDA065446_001Piperacillin / tazobactam Injection
5ANDA065458PIPERACILLIN AND TAZOBACTAMMYLAN LABORATORIES LTD2014-08-15ANDA065458_001, ANDA065458_002, ANDA065458_003Piperacillin / tazobactam Injection
6ANDA065498PIPERACILLIN AND TAZOBACTAMAUROBINDO PHARMA LTD2011-05-23ANDA065498_001, ANDA065498_002, ANDA065498_003Piperacillin / tazobactam Injection
7ANDA065523PIPERACILLIN AND TAZOBACTAMISTITUTO BIOCHIMICO ITALIANO SPA2011-05-31ANDA065523_001, ANDA065523_002, ANDA065523_003Piperacillin / tazobactam Injection
8ANDA090498PIPERACILLIN AND TAZOBACTAMISTITUTO BIOCHIMICO ITALIANO SPA2011-05-31ANDA090498_001Piperacillin / tazobactam Injection
9NDA050684ZOSYNWYETH PHARMACEUTICALS INC1993-10-22p6900184, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p8133883, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p7915229, SUBSTANCE
NDA050684_001, NDA050684_002, NDA050684_003, NDA050684_004Piperacillin / tazobactam Injection
10NDA050750ZOSYN IN PLASTIC CONTAINERWYETH PHARMACEUTICALS INC1998-02-24p6207661, SUBSTANCE
p6900184, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p8133883, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p7915229, SUBSTANCE
NDA050750_001, NDA050750_002, NDA050750_003Piperacillin / tazobactam Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065362_001RXTAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2010-10-21PIPERACILLIN AND TAZOBACTAM
2ANDA065362_002RXTAZOBACTAM SODIUM (EQ 375MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL)INJECTIONFalseAP2010-10-21PIPERACILLIN AND TAZOBACTAM
3ANDA065362_003RXPIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2010-10-21PIPERACILLIN AND TAZOBACTAM
4ANDA065363_001RXPIPERACILLIN SODIUM (EQ 2GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalseAP2010-10-21PIPERACILLIN AND TAZOBACTAM
5ANDA065363_002RXTAZOBACTAM SODIUM (EQ 375MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL)INJECTIONFalseAP2010-10-21PIPERACILLIN AND TAZOBACTAM
6ANDA065363_003RXPIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2010-10-21PIPERACILLIN AND TAZOBACTAM
7ANDA065386_001RXPIPERACILLIN SODIUM (EQ 2GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalseAP2009-09-15PIPERACILLIN AND TAZOBACTAM
8ANDA065386_002RXPIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL)INJECTIONFalseAP2009-09-15PIPERACILLIN AND TAZOBACTAM
9ANDA065386_003RXPIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-09-15PIPERACILLIN AND TAZOBACTAM
10ANDA065446_001RXPIPERACILLIN SODIUM (EQ 36GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 4.5GM BASE/VIAL)INJECTIONFalseAP2009-09-15PIPERACILLIN AND TAZOBACTAM
11ANDA065458_001RXTAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2014-08-15PIPERACILLIN AND TAZOBACTAM
12ANDA065458_002RXPIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL)INJECTIONFalseAP2014-08-15PIPERACILLIN AND TAZOBACTAM
13ANDA065458_003RXTAZOBACTAM SODIUM (EQ 500MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseAP2014-08-15PIPERACILLIN AND TAZOBACTAM
14ANDA065498_001RXTAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-05-23PIPERACILLIN AND TAZOBACTAM
15ANDA065498_002RXTAZOBACTAM SODIUM (EQ 375MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 3GM BASE/VIAL)INJECTIONFalseAP2011-05-23PIPERACILLIN AND TAZOBACTAM
16ANDA065498_003RXPIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2011-05-23PIPERACILLIN AND TAZOBACTAM
17ANDA065523_001RXPIPERACILLIN SODIUM (EQ 2GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalseAP2011-05-31PIPERACILLIN AND TAZOBACTAM
18ANDA065523_002RXPIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL)INJECTIONFalseAP2011-05-31PIPERACILLIN AND TAZOBACTAM
19ANDA065523_003RXTAZOBACTAM SODIUM (EQ 500MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseAP2011-05-31PIPERACILLIN AND TAZOBACTAM
20ANDA090498_001RXTAZOBACTAM SODIUM (EQ 4.5GM BASE/VIAL), PIPERACILLIN SODIUM (EQ 36GM BASE/VIAL)INJECTIONFalseAP2011-05-31PIPERACILLIN AND TAZOBACTAM
21NDA050684_001RXTAZOBACTAM SODIUM (EQ 250MG BASE/VIAL), PIPERACILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1993-10-22ZOSYN
22NDA050684_002RXPIPERACILLIN SODIUM (EQ 3GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 375MG BASE/VIAL)INJECTIONTrueAP1993-10-22ZOSYN
23NDA050684_003RXPIPERACILLIN SODIUM (EQ 4GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAP1993-10-22ZOSYN
24NDA050684_004RXTAZOBACTAM SODIUM (EQ 4.5GM BASE/VIAL), PIPERACILLIN SODIUM (EQ 36GM BASE/VIAL)INJECTIONTrueAP1993-10-22ZOSYN
25NDA050750_001RXPIPERACILLIN SODIUM (EQ 40MG BASE/ML), TAZOBACTAM SODIUM (EQ 5MG BASE/ML)INJECTIONTrue1998-02-24ZOSYN IN PLASTIC CONTAINER
26NDA050750_002RXTAZOBACTAM SODIUM (EQ 7.5MG BASE/ML), PIPERACILLIN SODIUM (EQ 60MG BASE/ML)INJECTIONTrue1998-02-24ZOSYN IN PLASTIC CONTAINER
27NDA050750_003RXPIPERACILLIN SODIUM (EQ 4GM BASE/100ML), TAZOBACTAM SODIUM (EQ 500MG BASE/100ML)INJECTIONTrue1998-02-24ZOSYN IN PLASTIC CONTAINER

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6207661 (view patent)2019-02-22NDA050750Piperacillin / tazobactam Injection
2p6900184 (view patent)2023-04-14NDA050684, NDA050750Piperacillin / tazobactam Injection
3p7915229 (view patent)2023-04-14NDA050684, NDA050750Piperacillin / tazobactam Injection
4p8133883 (view patent)2023-04-14NDA050684, NDA050750Piperacillin / tazobactam Injection

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
111c039a1-c9c2-3f82-fcc8-fc7443e409e5 (view SPL)These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN (piperacillin/tazobactam) FOR INJECTION: single-dose and pharmacy bulk vials ZOSYN (piperacillin/tazobactam) INJECTION: single dose GALAXY containers Initial U.S. approval: 1993prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-11-1119002062404, 002062405, 002062408, 002062409, 002062411, 002062413, 002062416Piperacillin / tazobactam Injection
217a400ae-cbaa-4d07-95f4-c6917dfc0585 (view SPL)These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionWg Critical Care, LlcMANUFACTURE2014-01-013445670804
323b0efbd-88e6-a8eb-b954-67c3e16846ba (view SPL)ZOSYN (Piperacillin and Tazobactam for Injection, USP)prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-09-2010002062416
42cfa6723-175b-4c4d-8212-266844b07610 (view SPL)These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-121633230304
57b3ba6b9-59e1-454a-9ddc-ab3592221627 (view SPL)These highlights do not include all the information needed to use Piperacillin and Tazobactam for Injection safely and effectively. See full prescribing information for Piperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection, USP: Pharmacy bulk vials Initial U.S. approval: 1993 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection, USP and other antibacterial drugs, Piperacillin and Tazobactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionApotex Corp2015-09-077605050773
681b0bb45-ce9d-43e7-b181-64315e14be55 (view SPL)ZOSYN (Piperacillin and Tazobactam for Injection, USP)prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-11-062002065501
7c08f0339-d24b-43c1-931b-77a36b120dfa (view SPL)These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN.ZOSYN (piperacillin/tazobactam) FOR INJECTION: single-dose and pharmacy bulk vialsInitial U.S. approval: 1993prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-08-066002065501, 002062501, 002063501, 002064501Piperacillin / tazobactam Injection
8c78e0931-ec79-58e5-8658-7fe692dc3b8b (view SPL)These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-01-014633230304
9e103a5e4-1d0b-4e1f-c69b-774f6ab70df1 (view SPL)These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN.ZOSYN (piperacillin/tazobactam) FOR INJECTION: single-dose and pharmacy bulk vialsZOSYN (piperacillin/tazobactam) INJECTION: single dose GALAXY containers Initial U.S. approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN and other antibacterial drugs, ZOSYN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-10-2819002068859, 002068852, 002068854, 002068855, 002068860, 002068861, 002068862Piperacillin / tazobactam Injection
10e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c (view SPL)These highlights do not include all the information needed to usePiperacillin and Tazobactam for Injection safely and effectively. See full prescribing information forPiperacillin and Tazobactam for Injection. Piperacillin and Tazobactam for Injection:pharmacy bulk package bottlesInitial U.S. Approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-121633230304

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