Ceftazidime Injection

Brand(s)
Fortaz, Tazicef
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Covis Pharmaceuticals, Inc. (2014-10-08)
Oldest Current Product
1986-03-06
License(s)
NDA, ANDA
RxNORM
INJECTION\CEFTAZIDIME
FDAOB
INJECTION\INJECTION\CEFTAZIDIME SODIUM\rdfq
INJECTION\INJECTION\CEFTAZIDIME\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFTAZIDIME
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CEFTAZIDIME SODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFTAZIDIME
INTRAVENOUS\INJECTION, SOLUTION\CEFTAZIDIME
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFTAZIDIME ANHYDROUS
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CEFTAZIDIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFTAZIDIME ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\CEFTAZIDIME ANHYDROUS

product(s) by strength(s)

ceftazidime 1000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643143NDAB. Braun Medical Inc.2011-06-13CEFTAZIDIMEINTRAVENOUSINJECTION, SOLUTIONNDA0508231b41f272-0727-4ce5-a4af-6255061a08b0
2249870378FortazNDACovis Pharmaceuticals, Inc.2012-12-14CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA050578981b9abe-4c76-41b2-8f36-eb3e28fa5adc
3249870412FortazNDACovis Pharmaceuticals, Inc.2013-04-15CEFTAZIDIMEINTRAVENOUSINJECTION, SOLUTIONNDA050634981b9abe-4c76-41b2-8f36-eb3e28fa5adc

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004095082TazicefANDAHospira, Inc.1986-03-06CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06266240d48c5d-650e-461b-a67b-7e65772d1b92
2004095092TazicefANDAHospira, Inc.1993-10-31CEFTAZIDIMEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0640329b73979c-c95a-4433-0a9d-f9cea3cb557f
3250210127ANDASagent Pharmaceuticals2008-05-15, 2015-07-01CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA062640112c5457-8d71-49f5-b531-9761d7d38c93, bfd92fd8-3014-44dd-b69b-4276262a51fa
4445670235ANDAWg Critical Care, Llc2013-01-31CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA062640bcc81df2-20e3-4738-bfcf-301da883c1d9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541125FortazNDACardinal Health1992-08-26CEFTAZIDIME SODIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION001730434NDA050578fd2fa2af-5929-4152-afd3-55e4e162f765

ceftazidime 2000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643145NDAB. Braun Medical Inc.2011-06-13CEFTAZIDIMEINTRAVENOUSINJECTION, SOLUTIONNDA0508231b41f272-0727-4ce5-a4af-6255061a08b0
2249870379FortazNDACovis Pharmaceuticals, Inc.2012-12-14CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA050578981b9abe-4c76-41b2-8f36-eb3e28fa5adc
3249870413FortazNDACovis Pharmaceuticals, Inc.2013-04-15CEFTAZIDIMEINTRAVENOUSINJECTION, SOLUTIONNDA050634981b9abe-4c76-41b2-8f36-eb3e28fa5adc

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004095084TazicefANDAHospira, Inc.1986-03-06CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06266240d48c5d-650e-461b-a67b-7e65772d1b92
2004095093TazicefANDAHospira, Inc.1993-10-31CEFTAZIDIMEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0640329b73979c-c95a-4433-0a9d-f9cea3cb557f
3250210128ANDASagent Pharmaceuticals2008-05-15, 2015-07-01CEFTAZIDIMEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062640112c5457-8d71-49f5-b531-9761d7d38c93, bfd92fd8-3014-44dd-b69b-4276262a51fa
4445670236ANDAWg Critical Care, Llc2013-01-31CEFTAZIDIMEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062640bcc81df2-20e3-4738-bfcf-301da883c1d9

ceftazidime 500 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870377FortazNDACovis Pharmaceuticals, Inc.2012-12-14CEFTAZIDIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA050578981b9abe-4c76-41b2-8f36-eb3e28fa5adc

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA062640CEFTAZIDIMEACS DOBFAR SPA1985-11-20ANDA062640_001, ANDA062640_002, ANDA062640_003, ANDA062640_004Ceftazidime Injectable Solution
2ANDA062655TAZIDIMETrueELI LILLY AND CO1985-11-20ANDA062655_001, ANDA062655_002Ceftazidime Injectable Solution
3ANDA062662TAZICEFHOSPIRA INC1986-03-06ANDA062662_001, ANDA062662_002, ANDA062662_003, ANDA062662_004Ceftazidime Injectable Solution
4ANDA062739TAZIDIME IN PLASTIC CONTAINERTrueELI LILLY AND CO1986-07-10ANDA062739_001, ANDA062739_002Ceftazidime Injectable Solution
5ANDA063221CEFTAZIDIME SODIUM IN PLASTIC CONTAINERTrueBAXTER HEALTHCARE CORP1993-04-29ANDA063221_001, ANDA063221_002, ANDA063221_003
6ANDA063322PENTACEFTrueGLAXOSMITHKLINE1995-11-07ANDA063322_001, ANDA063322_002Ceftazidime Injectable Solution
7ANDA064006PENTACEFTrueGLAXOSMITHKLINE1992-03-31ANDA064006_001, ANDA064006_002Ceftazidime Injectable Solution
8ANDA064008PENTACEFTrueGLAXOSMITHKLINE1992-03-31ANDA064008_001, ANDA064008_002Ceftazidime Injectable Solution
9ANDA064032TAZICEFHOSPIRA INC1993-10-31ANDA064032_001, ANDA064032_002Ceftazidime Injectable Solution
10ANDA065196CEFTAZIDIMEWOCKHARDT LTD2008-10-15ANDA065196_001Ceftazidime Injectable Solution
11ANDA065481CEFTAZIDIMETrueAUROBINDO PHARMA LTD2010-05-28ANDA065481_001, ANDA065481_002, ANDA065481_003Ceftazidime Injectable Solution
12ANDA065482CEFTAZIDIMETrueAUROBINDO PHARMA LTD2010-05-28ANDA065482_001Ceftazidime Injectable Solution
13NDA050578FORTAZIGI LABORATORIES INC1985-07-19NDA050578_001, NDA050578_002, NDA050578_003, NDA050578_004Ceftazidime Injectable Solution
14NDA050634FORTAZ IN PLASTIC CONTAINERIGI LABORATORIES INC1989-04-28NDA050634_001, NDA050634_002, NDA050634_003
15NDA050646CEPTAZTrueGLAXOSMITHKLINE1990-09-27NDA050646_001, NDA050646_002, NDA050646_003, NDA050646_004Ceftazidime Injectable Solution
16NDA050823CEFTAZIDIME IN DEXTROSE CONTAINERB BRAUN MEDICAL INC2011-06-13NDA050823_001, NDA050823_002Ceftazidime Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062640_001RXCEFTAZIDIME (500MG/VIAL)INJECTIONFalseAP1985-11-20CEFTAZIDIME
2ANDA062640_002RXCEFTAZIDIME (1GM/VIAL)INJECTIONFalseAP1985-11-20CEFTAZIDIME
3ANDA062640_003RXCEFTAZIDIME (2GM/VIAL)INJECTIONFalseAP1985-11-20CEFTAZIDIME
4ANDA062640_004RXCEFTAZIDIME (6GM/VIAL)INJECTIONFalseAP1992-02-03CEFTAZIDIME
5ANDA062655_001discontinuedCEFTAZIDIME (1GM/VIAL)INJECTIONFalse1985-11-20TAZIDIME
6ANDA062655_002discontinuedCEFTAZIDIME (2GM/VIAL)INJECTIONFalse1985-11-20TAZIDIME
7ANDA062662_001RXCEFTAZIDIME (500MG/VIAL)INJECTIONFalseAP1986-03-06TAZICEF
8ANDA062662_002RXCEFTAZIDIME (1GM/VIAL)INJECTIONFalseAP1986-03-06TAZICEF
9ANDA062662_003RXCEFTAZIDIME (2GM/VIAL)INJECTIONFalseAP1986-03-06TAZICEF
10ANDA062662_004RXCEFTAZIDIME (6GM/VIAL)INJECTIONFalseAP1986-03-06TAZICEF
11ANDA062739_001discontinuedCEFTAZIDIME (1GM/VIAL)INJECTIONFalse1986-07-10TAZIDIME IN PLASTIC CONTAINER
12ANDA062739_002discontinuedCEFTAZIDIME (2GM/VIAL)INJECTIONFalse1986-07-10TAZIDIME IN PLASTIC CONTAINER
13ANDA063221_001discontinuedCEFTAZIDIME SODIUM (EQ 10MG BASE/ML)INJECTIONFalse1993-04-29CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
14ANDA063221_002discontinuedCEFTAZIDIME SODIUM (EQ 20MG BASE/ML)INJECTIONFalse1993-04-29CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
15ANDA063221_003discontinuedCEFTAZIDIME SODIUM (EQ 40MG BASE/ML)INJECTIONFalse1993-04-29CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
16ANDA063322_001discontinuedCEFTAZIDIME (1GM/VIAL)INJECTIONFalse1995-11-07PENTACEF
17ANDA063322_002discontinuedCEFTAZIDIME (2GM/VIAL)INJECTIONFalse1995-11-07PENTACEF
18ANDA064006_001discontinuedCEFTAZIDIME (1GM/VIAL)INJECTIONFalse1992-03-31PENTACEF
19ANDA064006_002discontinuedCEFTAZIDIME (2GM/VIAL)INJECTIONFalse1992-03-31PENTACEF
20ANDA064008_001discontinuedCEFTAZIDIME (6GM/VIAL)INJECTIONFalse1992-03-31PENTACEF
21ANDA064008_002discontinuedCEFTAZIDIME (10GM/VIAL)INJECTIONFalse1992-03-31PENTACEF
22ANDA064032_001RXCEFTAZIDIME (1GM/VIAL)INJECTIONFalseAP1993-10-31TAZICEF
23ANDA064032_002RXCEFTAZIDIME (2GM/VIAL)INJECTIONFalseAP1993-10-31TAZICEF
24ANDA065196_001RXCEFTAZIDIME (1GM/VIAL)INJECTIONFalseAP2008-10-15CEFTAZIDIME
25ANDA065481_001discontinuedCEFTAZIDIME (500MG/VIAL)INJECTIONFalse2010-05-28CEFTAZIDIME
26ANDA065481_002discontinuedCEFTAZIDIME (1GM/VIAL)INJECTIONFalse2010-05-28CEFTAZIDIME
27ANDA065481_003discontinuedCEFTAZIDIME (2GM/VIAL)INJECTIONFalse2010-05-28CEFTAZIDIME
28ANDA065482_001discontinuedCEFTAZIDIME (6GM/VIAL)INJECTIONFalse2010-05-28CEFTAZIDIME
29NDA050578_001RXCEFTAZIDIME (500MG/VIAL)INJECTIONTrueAP1985-07-19FORTAZ
30NDA050578_002RXCEFTAZIDIME (1GM/VIAL)INJECTIONTrueAP1985-07-19FORTAZ
31NDA050578_003RXCEFTAZIDIME (2GM/VIAL)INJECTIONTrueAP1985-07-19FORTAZ
32NDA050578_004RXCEFTAZIDIME (6GM/VIAL)INJECTIONTrueAP1985-07-19FORTAZ
33NDA050634_001discontinuedCEFTAZIDIME SODIUM (EQ 10MG BASE/ML)INJECTIONFalse1989-04-28FORTAZ IN PLASTIC CONTAINER
34NDA050634_002RXCEFTAZIDIME SODIUM (EQ 20MG BASE/ML)INJECTIONTrue1989-04-28FORTAZ IN PLASTIC CONTAINER
35NDA050634_003RXCEFTAZIDIME SODIUM (EQ 40MG BASE/ML)INJECTIONTrue1989-04-28FORTAZ IN PLASTIC CONTAINER
36NDA050646_001discontinuedCEFTAZIDIME (500MG/VIAL)INJECTIONFalse1990-09-27CEPTAZ
37NDA050646_002discontinuedCEFTAZIDIME (1GM/VIAL)INJECTIONFalse1990-09-27CEPTAZ
38NDA050646_003discontinuedCEFTAZIDIME (2GM/VIAL)INJECTIONFalse1990-09-27CEPTAZ
39NDA050646_004discontinuedCEFTAZIDIME (10GM/VIAL)INJECTIONFalse1990-09-27CEPTAZ
40NDA050823_001RXCEFTAZIDIME (EQ 1GM BASE)INJECTIONFalse2011-06-13CEFTAZIDIME IN DEXTROSE CONTAINER
41NDA050823_002RXCEFTAZIDIME (EQ 2GM BASE)INJECTIONTrue2011-06-13CEFTAZIDIME IN DEXTROSE CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1112c5457-8d71-49f5-b531-9761d7d38c93 (view SPL)Ceftazidime for Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2015-01-086250210127, 250210128
21b41f272-0727-4ce5-a4af-6255061a08b0 (view SPL)These highlights do not include all the information needed to use CEFTAZIDIME for Injection USP and DEXTROSE Injection USP safely and effectively. See full prescribing information for CEFTAZIDIME for Injection USP and DEXTROSE Injection USP. C EFTAZIDIME for injection USP and DEXTROSE injection USP, for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionB. Braun Medical Inc.2015-05-2911002643143, 002643145
340d48c5d-650e-461b-a67b-7e65772d1b92 (view SPL)PRESCRIBING INFORMATIONRx only TAZICEF brand of ceftazidime for injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-10-272004095082, 004095084
4757c31dc-99ef-4960-b118-738b79631b1a (view SPL)Ceftazidime for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-07-2712007813177, 007813178
5981b9abe-4c76-41b2-8f36-eb3e28fa5adc (view SPL)FORTAZ (ceftazidime for injection)FORTAZ (ceftazidime injection)prescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.MANUFACTURE, PACK2014-10-085249870377, 249870378, 249870379, 249870412, 249870413, 249870382, 249870434, 249870435Ceftazidime Injectable Solution
69b73979c-c95a-4433-0a9d-f9cea3cb557f (view SPL)PRESCRIBING INFORMATIONTAZICEF Rx onlyprescriptionHuman PrescriptionHospira, Inc.2014-10-2714004095092, 004095093
7bcc81df2-20e3-4738-bfcf-301da883c1d9 (view SPL)Ceftazidime for InjectionprescriptionHuman PrescriptionWg Critical Care, Llc2015-01-222445670235, 445670236
8bfd92fd8-3014-44dd-b69b-4276262a51fa (view SPL)Ceftazidime for Injection, USPFor Intravenous or Intramuscular UseprescriptionHuman PrescriptionSagent Pharmaceuticals2015-03-132250210127, 250210128
9fd2fa2af-5929-4152-afd3-55e4e162f765 (view SPL)FORTAZ (ceftazidime for injection)FORTAZ (ceftazidime injection)prescriptionHuman PrescriptionCardinal HealthREPACK2011-06-131551541125

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