Piperacillin / tazobactam Injection

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

product(s) by strength(s)

piperacillin 2000 mg / tazobactam 250 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002062100ZosynNDAWyeth Pharmaceuticals, Inc.2013-12-18PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA050684dcef9e6b-b100-40e2-85b9-5ac4444f4ecf
2002062409ZosynNDAWyeth Pharmaceuticals, Inc.1998-03-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA05075011c039a1-c9c2-3f82-fcc8-fc7443e409e5, 8882e8d4-0a58-de3e-3987-68a5d326e046
3002068852ZosynNDAWyeth 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
1004093374ANDAHospira, Inc.2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06536391dea3bd-93fa-4f5b-8d2c-e0836de22674, b8e9c8cc-eba0-4f9a-a7ea-759eea242e5b
2004093383ANDAHospira, Inc.2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653624d3f4b69-b0b9-494f-9cda-4537fa420d47, 77622baa-3179-42ce-9799-8ca394a1d6e5
3007813110ANDASandoz Inc2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653629b682c66-61c6-4ade-baf4-9d68911a16b8
4007813344ANDASandoz Inc2011-05-31PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655233538e234-3f81-42e2-ad0c-a270e6a58ba3
5250210164ANDASagent Pharmaceuticals2011-06-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065498d4ebb2aa-9a61-4aba-ae75-dc8af0a4ab30
6445670801ANDAWg Critical Care, Llc2009-10-13PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655232cd82553-79dc-45f0-9755-2c08df524ed5
7551500119ANDAAuromedics Pharma Llc2012-01-23PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06549839e19789-de4b-4fd1-ab1c-92f59496f496
8605050686ANDAApotex Corp2009-09-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653867fabb534-4e46-481c-be86-cc7e1f85b1a7
9633230309ANDAApp Pharmaceuticals, Llc2009-10-13PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065523ba87ade3-4d41-40c0-9f6a-27e121a4136d, fc4d1e35-23eb-4654-8691-ae5bfd50a48a
10674570521ANDAMylan Institutional Llc2014-08-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065458e4cd6d4a-920b-41dc-a4ad-e0c7fc68b2e3
11761260069ANDAAgila Specialties Private Limited2014-08-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06545817b5597c-103c-426d-bff2-6c7398bd7619

piperacillin 3000 mg / tazobactam 375 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002062411ZosynNDAWyeth Pharmaceuticals, Inc.1998-03-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA05075011c039a1-c9c2-3f82-fcc8-fc7443e409e5, 8882e8d4-0a58-de3e-3987-68a5d326e046
2002063100ZosynNDAWyeth Pharmaceuticals, Inc.2013-12-18PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA050684dcef9e6b-b100-40e2-85b9-5ac4444f4ecf
3002068854ZosynNDAWyeth 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
1004093378ANDAHospira, Inc.2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06536391dea3bd-93fa-4f5b-8d2c-e0836de22674, b8e9c8cc-eba0-4f9a-a7ea-759eea242e5b
2004093385ANDAHospira, Inc.2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653624d3f4b69-b0b9-494f-9cda-4537fa420d47, 77622baa-3179-42ce-9799-8ca394a1d6e5
3007813113ANDASandoz Inc2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653629b682c66-61c6-4ade-baf4-9d68911a16b8
4007813350ANDASandoz Inc2011-05-31PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655233538e234-3f81-42e2-ad0c-a270e6a58ba3
5250210165ANDASagent Pharmaceuticals2011-06-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065498d4ebb2aa-9a61-4aba-ae75-dc8af0a4ab30
6445670802ANDAWg Critical Care, Llc2009-10-13PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655232cd82553-79dc-45f0-9755-2c08df524ed5
7551500120ANDAAuromedics Pharma Llc2012-01-23PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06549839e19789-de4b-4fd1-ab1c-92f59496f496
8605050687ANDAApotex Corp2009-09-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653867fabb534-4e46-481c-be86-cc7e1f85b1a7
9633230300ANDAApp Pharmaceuticals, Llc2009-10-13PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065523ba87ade3-4d41-40c0-9f6a-27e121a4136d, fc4d1e35-23eb-4654-8691-ae5bfd50a48a
10674570522ANDAMylan Institutional Llc2014-08-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065458e4cd6d4a-920b-41dc-a4ad-e0c7fc68b2e3

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544228ZosynNDACardinal Health1993-11-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION002068854NDA050684db7aa1c2-22e6-492f-81ba-5ecbb8836ac0
2551549386ANDACardinal Health2011-05-31PIPERACILLIN, TAZOBACTAMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION633230300ANDA0655237b687747-bf51-4366-9277-29bc82fc665a

piperacillin 4000 mg / tazobactam 500 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002062413ZosynNDAWyeth Pharmaceuticals, Inc.1998-03-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA05075011c039a1-c9c2-3f82-fcc8-fc7443e409e5, 8882e8d4-0a58-de3e-3987-68a5d326e046
2002068855ZosynNDAWyeth Pharmaceuticals, Inc.1993-11-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA050684e103a5e4-1d0b-4e1f-c69b-774f6ab70df1
3002068862ZosynNDAWyeth Pharmaceuticals, Inc.1998-03-01PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA050750e103a5e4-1d0b-4e1f-c69b-774f6ab70df1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093379ANDAHospira, Inc.2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06536391dea3bd-93fa-4f5b-8d2c-e0836de22674, b8e9c8cc-eba0-4f9a-a7ea-759eea242e5b
2004093390ANDAHospira, Inc.2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653624d3f4b69-b0b9-494f-9cda-4537fa420d47, 77622baa-3179-42ce-9799-8ca394a1d6e5
3007813114ANDASandoz Inc2010-10-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653629b682c66-61c6-4ade-baf4-9d68911a16b8
4007813367ANDASandoz Inc2011-05-31PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655233538e234-3f81-42e2-ad0c-a270e6a58ba3
5250210166ANDASagent Pharmaceuticals2011-06-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065498d4ebb2aa-9a61-4aba-ae75-dc8af0a4ab30
6445670803ANDAWg Critical Care, Llc2009-10-13PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655232cd82553-79dc-45f0-9755-2c08df524ed5
7551500121ANDAAuromedics Pharma Llc2012-01-23PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06549839e19789-de4b-4fd1-ab1c-92f59496f496
8605050688ANDAApotex Corp2009-09-21PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653867fabb534-4e46-481c-be86-cc7e1f85b1a7
9633230320ANDAApp Pharmaceuticals, Llc2009-10-13PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065523ba87ade3-4d41-40c0-9f6a-27e121a4136d, fc4d1e35-23eb-4654-8691-ae5bfd50a48a
10674570523ANDAMylan Institutional Llc2014-08-16PIPERACILLIN SODIUM, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065458e4cd6d4a-920b-41dc-a4ad-e0c7fc68b2e3

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA065362PIPERACILLIN AND TAZOBACTAMSANDOZ INC2010-10-21ANDA065362_001, ANDA065362_002, ANDA065362_003Piperacillin / tazobactam Injectable Solution
2ANDA065363PIPERACILLIN AND TAZOBACTAMSANDOZ INC2010-10-21ANDA065363_001, ANDA065363_002, ANDA065363_003Piperacillin / tazobactam Injectable Solution
3ANDA065386PIPERACILLIN AND TAZOBACTAMHOSPIRA INC2009-09-15ANDA065386_001, ANDA065386_002, ANDA065386_003Piperacillin / tazobactam Injectable Solution
4ANDA065446PIPERACILLIN AND TAZOBACTAMHOSPIRA INC2009-09-15ANDA065446_001Piperacillin / tazobactam Injectable Solution
5ANDA065458PIPERACILLIN AND TAZOBACTAMMYLAN LABORATORIES LTD2014-08-15ANDA065458_001, ANDA065458_002, ANDA065458_003Piperacillin / tazobactam Injectable Solution
6ANDA065498PIPERACILLIN AND TAZOBACTAMAUROBINDO PHARMA LTD2011-05-23ANDA065498_001, ANDA065498_002, ANDA065498_003Piperacillin / tazobactam Injectable Solution
7ANDA065523PIPERACILLIN AND TAZOBACTAMISTITUTO BIOCHIMICO ITALIANO SPA2011-05-31ANDA065523_001, ANDA065523_002, ANDA065523_003Piperacillin / tazobactam Injectable Solution
8ANDA090498PIPERACILLIN AND TAZOBACTAMISTITUTO BIOCHIMICO ITALIANO SPA2011-05-31ANDA090498_001Piperacillin / tazobactam Injectable Solution
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 Injectable Solution
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 Injectable Solution

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 Injectable Solution
2p6900184 (view patent)2023-04-14NDA050684, NDA050750Piperacillin / tazobactam Injectable Solution
3p7915229 (view patent)2023-04-14NDA050684, NDA050750Piperacillin / tazobactam Injectable Solution
4p8133883 (view patent)2023-04-14NDA050684, NDA050750Piperacillin / tazobactam Injectable Solution

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, PACK2015-11-1119002062409, 002062411, 002062413, 002062404, 002062405, 002062408, 002062416Piperacillin / tazobactam Injectable Solution
217b5597c-103c-426d-bff2-6c7398bd7619 (view SPL)These highlights do not include all the information needed to use Piperacillin and Tazobactum for Injection safely and effectively. See full prescribing information for Piperacillin and Tazobactum for Injection.PIPERACILLIN AND TAZOBACTAM FOR INJECTION: single dose vialsInitial U.S. approval: 1993To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam 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 PrescriptionAgila Specialties Private LimitedAnalysis, Manufacture, Pack, Sterilize2014-07-203761260069
32cd82553-79dc-45f0-9755-2c08df524ed5 (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: single-dose vials Initial 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, Llc2015-06-194445670801, 445670802, 445670803
43538e234-3f81-42e2-ad0c-a270e6a58ba3 (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: single-dose vials Initial U.S. Approval: 1993prescriptionHuman PrescriptionSandoz IncAPI MANUFACTURE, MANUFACTURE2014-04-012007813344, 007813350, 007813367
539e19789-de4b-4fd1-ab1c-92f59496f496 (view SPL)These highlights do not include all the information needed to use piperacillin and tazobactam for injection, USP safely and effectively. See full prescribing information for piperacillin and tazobactam for injection, USP.PIPERACILLIN AND TAZOBACTAM FOR INJECTION, USP: single-dose vials, for intravenous useInitial U.S. approval: 1993To 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 should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-147551500119, 551500120, 551500121
64d3f4b69-b0b9-494f-9cda-4537fa420d47 (view SPL)These highlights do not include all the information needed to use PIPERACILLIN and TAZOBACTAM FOR INJECTION USP safely and effectively. See full prescribing information for PIPERACILLIN and TAZOBACTAM FOR INJECTION USP. PIPERACILLIN and TAZOBACTAM FOR INJECTION USP, single-dose vialsInitial U.S. Approval: 1993prescriptionHuman PrescriptionHospira, Inc.2013-09-3013004093383, 004093385, 004093390
777622baa-3179-42ce-9799-8ca394a1d6e5 (view SPL)These highlights do not include all the information needed to use PIPERACILLIN and TAZOBACTAM FOR INJECTION USP safely and effectively. See full prescribing information for PIPERACILLIN and TAZOBACTAM FOR INJECTION USP. PIPERACILLIN and TAZOBACTAM FOR INJECTION USP, single-dose vialsInitial U.S. Approval: 1993prescriptionHuman PrescriptionHospira, Inc.2013-09-3014004093383, 004093385, 004093390
87b687747-bf51-4366-9277-29bc82fc665a (view SPL)Piperacillin and Tazobactam for InjectionprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-291551549386
97fabb534-4e46-481c-be86-cc7e1f85b1a7 (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: Single-dose 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 Corp2015-09-078605050686, 605050687, 605050688
108882e8d4-0a58-de3e-3987-68a5d326e046 (view SPL)ZOSYN (Piperacillin and Tazobactam Injection)in Galaxy Containers (PL 2040 Plastic)prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2013-07-1511002062409, 002062411, 002062413
1191dea3bd-93fa-4f5b-8d2c-e0836de22674 (view SPL)These highlights do not include all the information needed to use PIPERACILLIN and TAZOBACTAM FOR INJECTION USP safely and effectively. See full prescribing information for PIPERACILLIN and TAZOBACTAM FOR INJECTION USP. PIPERACILLIN and TAZOBACTAM FOR INJECTION USP, ADD-Vantage vialsInitial U.S. Approval: 1993prescriptionHuman PrescriptionHospira, Inc.2013-09-3013004093374, 004093378, 004093379
129b682c66-61c6-4ade-baf4-9d68911a16b8 (view SPL)These highlights do not include all the information needed to use PIPERACILLIN and TAZOBACTAM FOR INJECTION USP safely and effectively. See full prescribing information for PIPERACILLIN and TAZOBACTAM FOR INJECTION USP. PIPERACILLIN and TAZOBACTAM FOR INJECTION USP, single-dose vialsInitial U.S. Approval: 1993prescriptionHuman PrescriptionSandoz Inc2013-09-3017007813110, 007813113, 007813114
13b8e9c8cc-eba0-4f9a-a7ea-759eea242e5b (view SPL)These highlights do not include all the information needed to use PIPERACILLIN and TAZOBACTAM FOR INJECTION USP safely and effectively. See full prescribing information for PIPERACILLIN and TAZOBACTAM FOR INJECTION USP. PIPERACILLIN and TAZOBACTAM FOR INJECTION USP, ADD-Vantage vialsInitial U.S. Approval: 1993prescriptionHuman PrescriptionHospira, Inc.2013-09-3015004093374, 004093378, 004093379
14ba87ade3-4d41-40c0-9f6a-27e121a4136d (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: single-dose vials Initial 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, Llc2015-06-191633230300, 633230309, 633230320
15c08f0339-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, PACK2015-08-066002062501, 002063501, 002064501, 002065501Piperacillin / tazobactam Injectable Solution
16d4ebb2aa-9a61-4aba-ae75-dc8af0a4ab30 (view SPL)These highlights do not include all the information needed to use piperacillin and tazobactam for injection, USP safely and effectively. See full prescribing information for piperacillin and tazobactam for injection, USP.PIPERACILLIN AND TAZOBACTAM FOR INJECTION, USP: single-dose vials, for intravenous useInitial U.S. approval: 1993prescriptionHuman PrescriptionSagent Pharmaceuticals2013-11-305250210164, 250210165, 250210166
17db7aa1c2-22e6-492f-81ba-5ecbb8836ac0 (view SPL)Zosyn (Piperacillin and Tazobactam for Injection, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2011-06-071551544228
18dcef9e6b-b100-40e2-85b9-5ac4444f4ecf (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 vialsInitial U.S. approval: 1993prescriptionHuman PrescriptionWyeth Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-162002062100, 002063100, 002064100
19e103a5e4-1d0b-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, PACK2015-10-2819002068852, 002068854, 002068855, 002068862, 002068859, 002068860, 002068861Piperacillin / tazobactam Injectable Solution
20e4cd6d4a-920b-41dc-a4ad-e0c7fc68b2e3 (view SPL)These highlights do not include all the information needed to use Piperacillin and Tazobactam for Injection, USP safely and effectively. See full prescribing information for Piperacillin and Tazobactam for Injection, USP.PIPERACILLIN and TAZOBACTAM for injection, USP for intravenous use only: single dose vialsInitial U.S. approval: 1993To 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 PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-07-142674570521, 674570522, 674570523
21fc4d1e35-23eb-4654-8691-ae5bfd50a48a (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: single-dose vials Initial 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, Llc2015-06-194633230300, 633230309, 633230320

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