Ampicillin / Sulbactam Injectable Solution

Brand(s)
Unasyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roerig (2015-01-16)
Oldest Current Product
1991-11-22
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\AMPICILLIN:SULBACTAM
FDAOB
INJECTION\INJECTION\AMPICILLIN SODIUM: SULBACTAM SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\AMPICILLIN SODIUM: SULBACTAM SODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\AMPICILLIN SODIUM: SULBACTAM SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\AMPICILLIN: SULBACTAM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\AMPICILLIN: SULBACTAM

product(s) by strength(s)

ampicillin 100 mg/ml / sulbactam 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000490024UnasynNDARoerig1991-11-22AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA05060812eeb72a-403d-41be-bae4-4cb930862884

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092687ANDAHospira, Inc.2006-07-25, 2012-03-19AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065240, ANDA0906461edd149e-02ff-4500-ae1d-f3334af39dd6, c391d5ce-3d04-4b80-8847-7afdc0aaa8b6
2006416118ANDAWest-Ward Pharmaceuticals Corp.2009-12-03AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065403a65a70bf-4283-4bc0-b576-00c9ab29bd64
3006416121ANDAWest-Ward Pharmaceuticals Corp.2009-12-03AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06540329a3c93c-3be2-441d-b59d-fd7bbc8961da
4007813034ANDASandoz Inc2006-07-25AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06524046b944ac-3913-495f-9b7a-68ef0fd46044
5250210144ANDASagent Pharmaceuticals2010-08-12AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06540335606b43-5914-423c-9bc7-fa3957eb2563
6445670212ANDAWg Critical Care, Llc2005-11-25AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06518877158167-0c1e-4f01-a5b0-a3df8ad121f5
7551500118ANDAAuromedics Pharma Llc2012-02-10AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0903392709e9fc-2341-4382-af72-c2e3201bd77a
8633230370ANDAApp Pharmaceuticals, Llc2006-11-27AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653147a7a6041-f76c-4507-bf58-99e119328991
9674570649ANDAMylan Institutional Llc2014-04-08AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA202197ce394e7a-4a5f-4d52-ba16-d53070a40790
10761260049ANDAAgila Specialties Private Limited2014-04-08AMPICILLIN SODIUM, SULBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA202197dc32d2db-3605-4c68-b1c9-71fb6c87e42c

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA062901UNASYNPFIZER LABORATORIES DIV PFIZER INC1988-11-23ANDA062901_001, ANDA062901_002Ampicillin / Sulbactam Injection
2ANDA065074AMPICILLIN AND SULBACTAMHIKMA MAPLE LTD2002-03-19ANDA065074_001, ANDA065074_002Ampicillin / Sulbactam Injection
3ANDA065076AMPICILLIN AND SULBACTAMHIKMA MAPLE LTD2002-03-19ANDA065076_001Ampicillin / Sulbactam Injection
4ANDA065176AMPICILLIN AND SULBACTAMGC HANFORD MANUFACTURING CO2005-11-30ANDA065176_001, ANDA065176_002Ampicillin / Sulbactam Injection
5ANDA065188AMPICILLIN AND SULBACTAMGC HANFORD MANUFACTURING CO2005-11-25ANDA065188_001Ampicillin / Sulbactam Injection
6ANDA065222AMPICILLIN AND SULBACTAMISTITUTO BIOCHIMICO ITALIANO SPA2005-11-29ANDA065222_001, ANDA065222_002Ampicillin / Sulbactam Injection
7ANDA065240AMPICILLIN AND SULBACTAMSANDOZ INC2006-07-25ANDA065240_001Ampicillin / Sulbactam Injection
8ANDA065241AMPICILLIN AND SULBACTAMSANDOZ INC2006-07-25ANDA065241_001, ANDA065241_002Ampicillin / Sulbactam Injection
9ANDA065310AMPICILLIN AND SULBACTAMSANDOZ INC2006-07-25ANDA065310_001, ANDA065310_002Ampicillin / Sulbactam Injection
10ANDA065314AMPICILLIN AND SULBACTAMISTITUTO BIOCHIMICO ITALIANO SPA2006-11-27ANDA065314_001Ampicillin / Sulbactam Injection
11ANDA065316AMPICILLIN AND SULBACTAMMUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)2007-06-29ANDA065316_001, ANDA065316_002Ampicillin / Sulbactam Injection
12ANDA065403AMPICILLIN AND SULBACTAMACS DOBFAR SPA2009-12-23ANDA065403_001Ampicillin / Sulbactam Injection
13ANDA065406AMPICILLIN AND SULBACTAMACS DOBFAR SPA2009-12-22ANDA065406_001, ANDA065406_002Ampicillin / Sulbactam Injection
14ANDA090339AMPICILLIN AND SULBACTAMAUROBINDO PHARMA2010-09-20ANDA090339_001Ampicillin / Sulbactam Injection
15ANDA090340AMPICILLIN AND SULBACTAMAUROBINDO PHARMA2010-09-20ANDA090340_001, ANDA090340_002Ampicillin / Sulbactam Injection
16ANDA090349AMPICILLIN AND SULBACTAMAUROBINDO PHARMA2010-09-20ANDA090349_001, ANDA090349_002Ampicillin / Sulbactam Injection
17ANDA090375AMPICILLIN AND SULBACTAMHOSPIRA INC2011-12-21ANDA090375_001, ANDA090375_002Ampicillin / Sulbactam Injection
18ANDA090646AMPICILLIN AND SULBACTAMHOSPIRA INC2011-12-21ANDA090646_001Ampicillin / Sulbactam Injection
19ANDA090653AMPICILLIN AND SULBACTAMHOSPIRA INC2011-12-21ANDA090653_001, ANDA090653_002Ampicillin / Sulbactam Injection
20ANDA201024AMPICILLIN AND SULBACTAMMYLAN LABORATORIES LTD2014-04-07ANDA201024_001, ANDA201024_002Ampicillin / Sulbactam Injection
21ANDA202197AMPICILLIN AND SULBACTAMMYLAN LABORATORIES LTD2014-04-07ANDA202197_001Ampicillin / Sulbactam Injection
22NDA050608UNASYNPFIZER INC1986-12-31NDA050608_001, NDA050608_002, NDA050608_003, NDA050608_005Ampicillin / Sulbactam Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062901_001RXAMPICILLIN SODIUM (EQ 1GM BASE/VIAL), SULBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAP1988-11-23UNASYN
2ANDA062901_002RXSULBACTAM SODIUM (EQ 1GM BASE/VIAL), AMPICILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1992-02-27UNASYN
3ANDA065074_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2002-03-19AMPICILLIN AND SULBACTAM
4ANDA065074_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2002-03-19AMPICILLIN AND SULBACTAM
5ANDA065076_001RXAMPICILLIN SODIUM (EQ 10GM BASE/VIAL), SULBACTAM SODIUM (EQ 5GM BASE/VIAL)INJECTIONFalseAP2002-03-19AMPICILLIN AND SULBACTAM
6ANDA065176_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2005-11-30AMPICILLIN AND SULBACTAM
7ANDA065176_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2005-11-30AMPICILLIN AND SULBACTAM
8ANDA065188_001RXSULBACTAM SODIUM (EQ 5GM BASE/VIAL), AMPICILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2005-11-25AMPICILLIN AND SULBACTAM
9ANDA065222_001RXAMPICILLIN SODIUM (EQ 1GM BASE/VIAL), SULBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2005-11-29AMPICILLIN AND SULBACTAM
10ANDA065222_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2005-11-29AMPICILLIN AND SULBACTAM
11ANDA065240_001RXAMPICILLIN SODIUM (EQ 10GM BASE/VIAL), SULBACTAM SODIUM (EQ 5GM BASE/VIAL)INJECTIONFalseAP2006-07-25AMPICILLIN AND SULBACTAM
12ANDA065241_001RXAMPICILLIN SODIUM (EQ 1GM BASE/VIAL), SULBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2006-07-25AMPICILLIN AND SULBACTAM
13ANDA065241_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-07-25AMPICILLIN AND SULBACTAM
14ANDA065310_001RXAMPICILLIN SODIUM (EQ 1GM BASE/VIAL), SULBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2006-07-25AMPICILLIN AND SULBACTAM
15ANDA065310_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-07-25AMPICILLIN AND SULBACTAM
16ANDA065314_001RXSULBACTAM SODIUM (EQ 5GM BASE/VIAL), AMPICILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2006-11-27AMPICILLIN AND SULBACTAM
17ANDA065316_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2007-06-29AMPICILLIN AND SULBACTAM
18ANDA065316_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2007-06-29AMPICILLIN AND SULBACTAM
19ANDA065403_001RXSULBACTAM SODIUM (EQ 5GM BASE/VIAL), AMPICILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2009-12-23AMPICILLIN AND SULBACTAM
20ANDA065406_001RXAMPICILLIN SODIUM (EQ 1GM BASE/VIAL), SULBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-12-22AMPICILLIN AND SULBACTAM
21ANDA065406_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2009-12-22AMPICILLIN AND SULBACTAM
22ANDA090339_001RXSULBACTAM SODIUM (EQ 5GM BASE/VIAL), AMPICILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2010-09-20AMPICILLIN AND SULBACTAM
23ANDA090340_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2010-09-20AMPICILLIN AND SULBACTAM
24ANDA090340_002RXSULBACTAM SODIUM (EQ 1GM BASE/VIAL), AMPICILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2010-09-20AMPICILLIN AND SULBACTAM
25ANDA090349_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2010-09-20AMPICILLIN AND SULBACTAM
26ANDA090349_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2010-09-20AMPICILLIN AND SULBACTAM
27ANDA090375_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-12-21AMPICILLIN AND SULBACTAM
28ANDA090375_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-12-21AMPICILLIN AND SULBACTAM
29ANDA090646_001RXSULBACTAM SODIUM (EQ 5GM BASE/VIAL), AMPICILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2011-12-21AMPICILLIN AND SULBACTAM
30ANDA090653_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-12-21AMPICILLIN AND SULBACTAM
31ANDA090653_002RXSULBACTAM SODIUM (EQ 1GM BASE/VIAL), AMPICILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-12-21AMPICILLIN AND SULBACTAM
32ANDA201024_001RXSULBACTAM SODIUM (EQ 500MG BASE/VIAL), AMPICILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2014-04-07AMPICILLIN AND SULBACTAM
33ANDA201024_002RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2014-04-07AMPICILLIN AND SULBACTAM
34ANDA202197_001RXAMPICILLIN SODIUM (EQ 10GM BASE/VIAL), SULBACTAM SODIUM (EQ 5GM BASE/VIAL)INJECTIONFalseAP2014-04-07AMPICILLIN AND SULBACTAM
35NDA050608_001RXAMPICILLIN SODIUM (EQ 2GM BASE/VIAL), SULBACTAM SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1986-12-31UNASYN
36NDA050608_002RXAMPICILLIN SODIUM (EQ 1GM BASE/VIAL), SULBACTAM SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAP1986-12-31UNASYN
37NDA050608_003discontinuedAMPICILLIN SODIUM (EQ 500MG BASE/VIAL), SULBACTAM SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1986-12-31UNASYN
38NDA050608_005RXAMPICILLIN SODIUM (EQ 10GM BASE/VIAL), SULBACTAM SODIUM (EQ 5GM BASE/VIAL)INJECTIONTrueAP1993-12-10UNASYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112eeb72a-403d-41be-bae4-4cb930862884 (view SPL)UNASYN (ampicillin sodium/sulbactam sodium)prescriptionHuman PrescriptionRoerigAPI MANUFACTURE, MANUFACTURE2015-01-1616000490024
21edd149e-02ff-4500-ae1d-f3334af39dd6 (view SPL)Ampicillin and Sulbactam for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-12-0213004092687
32709e9fc-2341-4382-af72-c2e3201bd77a (view SPL)STERILEAMPICILLIN AND SULBACTAM FOR INJECTION, USP PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSIONRx onlyprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-154551500118
429a3c93c-3be2-441d-b59d-fd7bbc8961da (view SPL)Ampicillin and Sulbactam for Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2015-06-195006416121
535606b43-5914-423c-9bc7-fa3957eb2563 (view SPL)AMPICILLIN AND SULBACTAM FOR INJECTION, USP(For IV Use)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-08-146250210144
646b944ac-3913-495f-9b7a-68ef0fd46044 (view SPL)Ampicillin and Sulbactam for Injection, USPprescriptionHuman PrescriptionSandoz Inc2014-12-0215007813034
777158167-0c1e-4f01-a5b0-a3df8ad121f5 (view SPL)AMPICILLIN AND SULBACTAM FOR INJECTION, USPprescriptionHuman PrescriptionWg Critical Care, Llc2014-03-034445670212
87a7a6041-f76c-4507-bf58-99e119328991 (view SPL)AMPICILLIN AND SULBACTAM FOR INJECTION, USPprescriptionHuman PrescriptionApp Pharmaceuticals, Llcmanufacture2007-11-151633230370
9a65a70bf-4283-4bc0-b576-00c9ab29bd64 (view SPL)AMPICILLIN AND SULBACTAM FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2015-05-155006416118
10c391d5ce-3d04-4b80-8847-7afdc0aaa8b6 (view SPL)Ampicillin and Sulbactam for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-06-306004092687
11ce394e7a-4a5f-4d52-ba16-d53070a40790 (view SPL)prescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-07-241674570649
12dc32d2db-3605-4c68-b1c9-71fb6c87e42c (view SPL)Ampicillin and Sulbactam for Injection, USPprescriptionHuman PrescriptionAgila Specialties Private LimitedAnalysis, Manufacture, Pack, Sterilize2014-04-101761260049

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