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)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	002643143		NDA	B. Braun Medical Inc.	2011-06-13	CEFTAZIDIME	INTRAVENOUS	INJECTION, SOLUTION	NDA050823	1b41f272-0727-4ce5-a4af-6255061a08b0
2	249870378	Fortaz	NDA	Covis Pharmaceuticals, Inc.	2012-12-14	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	NDA050578	981b9abe-4c76-41b2-8f36-eb3e28fa5adc
3	249870412	Fortaz	NDA	Covis Pharmaceuticals, Inc.	2013-04-15	CEFTAZIDIME	INTRAVENOUS	INJECTION, SOLUTION	NDA050634	981b9abe-4c76-41b2-8f36-eb3e28fa5adc

generic product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004095082	Tazicef	ANDA	Hospira, Inc.	1986-03-06	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	ANDA062662	40d48c5d-650e-461b-a67b-7e65772d1b92
2	004095092	Tazicef	ANDA	Hospira, Inc.	1993-10-31	CEFTAZIDIME	INTRAVENOUS	INJECTION, POWDER, FOR SOLUTION	ANDA064032	9b73979c-c95a-4433-0a9d-f9cea3cb557f
3	250210127		ANDA	Sagent Pharmaceuticals	2008-05-15, 2015-07-01	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	ANDA062640	112c5457-8d71-49f5-b531-9761d7d38c93, bfd92fd8-3014-44dd-b69b-4276262a51fa
4	445670235		ANDA	Wg Critical Care, Llc	2013-01-31	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	ANDA062640	bcc81df2-20e3-4738-bfcf-301da883c1d9

relabeler product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	551541125	Fortaz	NDA	Cardinal Health	1992-08-26	CEFTAZIDIME SODIUM	INTRAMUSCULAR	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	001730434	NDA050578	fd2fa2af-5929-4152-afd3-55e4e162f765

ceftazidime 2000 mg injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	002643145		NDA	B. Braun Medical Inc.	2011-06-13	CEFTAZIDIME	INTRAVENOUS	INJECTION, SOLUTION	NDA050823	1b41f272-0727-4ce5-a4af-6255061a08b0
2	249870379	Fortaz	NDA	Covis Pharmaceuticals, Inc.	2012-12-14	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	NDA050578	981b9abe-4c76-41b2-8f36-eb3e28fa5adc
3	249870413	Fortaz	NDA	Covis Pharmaceuticals, Inc.	2013-04-15	CEFTAZIDIME	INTRAVENOUS	INJECTION, SOLUTION	NDA050634	981b9abe-4c76-41b2-8f36-eb3e28fa5adc

generic product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004095084	Tazicef	ANDA	Hospira, Inc.	1986-03-06	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	ANDA062662	40d48c5d-650e-461b-a67b-7e65772d1b92
2	004095093	Tazicef	ANDA	Hospira, Inc.	1993-10-31	CEFTAZIDIME	INTRAVENOUS	INJECTION, POWDER, FOR SOLUTION	ANDA064032	9b73979c-c95a-4433-0a9d-f9cea3cb557f
3	250210128		ANDA	Sagent Pharmaceuticals	2008-05-15, 2015-07-01	CEFTAZIDIME	INTRAVENOUS	INJECTION, POWDER, FOR SOLUTION	ANDA062640	112c5457-8d71-49f5-b531-9761d7d38c93, bfd92fd8-3014-44dd-b69b-4276262a51fa
4	445670236		ANDA	Wg Critical Care, Llc	2013-01-31	CEFTAZIDIME	INTRAVENOUS	INJECTION, POWDER, FOR SOLUTION	ANDA062640	bcc81df2-20e3-4738-bfcf-301da883c1d9

ceftazidime 500 mg injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	249870377	Fortaz	NDA	Covis Pharmaceuticals, Inc.	2012-12-14	CEFTAZIDIME	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	NDA050578	981b9abe-4c76-41b2-8f36-eb3e28fa5adc

application(s)

#	id	title	deprecated	applicant	approved	approved drug	in other drug docs
1	ANDA062640	CEFTAZIDIME		ACS DOBFAR SPA	1985-11-20	ANDA062640_001, ANDA062640_002, ANDA062640_003, ANDA062640_004	Ceftazidime Injectable Solution
2	ANDA062655	TAZIDIME	True	ELI LILLY AND CO	1985-11-20	ANDA062655_001, ANDA062655_002	Ceftazidime Injectable Solution
3	ANDA062662	TAZICEF		HOSPIRA INC	1986-03-06	ANDA062662_001, ANDA062662_002, ANDA062662_003, ANDA062662_004	Ceftazidime Injectable Solution
4	ANDA062739	TAZIDIME IN PLASTIC CONTAINER	True	ELI LILLY AND CO	1986-07-10	ANDA062739_001, ANDA062739_002	Ceftazidime Injectable Solution
5	ANDA063221	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER	True	BAXTER HEALTHCARE CORP	1993-04-29	ANDA063221_001, ANDA063221_002, ANDA063221_003
6	ANDA063322	PENTACEF	True	GLAXOSMITHKLINE	1995-11-07	ANDA063322_001, ANDA063322_002	Ceftazidime Injectable Solution
7	ANDA064006	PENTACEF	True	GLAXOSMITHKLINE	1992-03-31	ANDA064006_001, ANDA064006_002	Ceftazidime Injectable Solution
8	ANDA064008	PENTACEF	True	GLAXOSMITHKLINE	1992-03-31	ANDA064008_001, ANDA064008_002	Ceftazidime Injectable Solution
9	ANDA064032	TAZICEF		HOSPIRA INC	1993-10-31	ANDA064032_001, ANDA064032_002	Ceftazidime Injectable Solution
10	ANDA065196	CEFTAZIDIME		WOCKHARDT LTD	2008-10-15	ANDA065196_001	Ceftazidime Injectable Solution
11	ANDA065481	CEFTAZIDIME	True	AUROBINDO PHARMA LTD	2010-05-28	ANDA065481_001, ANDA065481_002, ANDA065481_003	Ceftazidime Injectable Solution
12	ANDA065482	CEFTAZIDIME	True	AUROBINDO PHARMA LTD	2010-05-28	ANDA065482_001	Ceftazidime Injectable Solution
13	NDA050578	FORTAZ		IGI LABORATORIES INC	1985-07-19	NDA050578_001, NDA050578_002, NDA050578_003, NDA050578_004	Ceftazidime Injectable Solution
14	NDA050634	FORTAZ IN PLASTIC CONTAINER		IGI LABORATORIES INC	1989-04-28	NDA050634_001, NDA050634_002, NDA050634_003
15	NDA050646	CEPTAZ	True	GLAXOSMITHKLINE	1990-09-27	NDA050646_001, NDA050646_002, NDA050646_003, NDA050646_004	Ceftazidime Injectable Solution
16	NDA050823	CEFTAZIDIME IN DEXTROSE CONTAINER		B BRAUN MEDICAL INC	2011-06-13	NDA050823_001, NDA050823_002	Ceftazidime Injectable Solution

application drug(s)

#	id	category/deprecated	ingredient strength(s)	dose form	rld	TE	approved	application
1	ANDA062640_001	RX	CEFTAZIDIME (500MG/VIAL)	INJECTION	False	AP	1985-11-20	CEFTAZIDIME
2	ANDA062640_002	RX	CEFTAZIDIME (1GM/VIAL)	INJECTION	False	AP	1985-11-20	CEFTAZIDIME
3	ANDA062640_003	RX	CEFTAZIDIME (2GM/VIAL)	INJECTION	False	AP	1985-11-20	CEFTAZIDIME
4	ANDA062640_004	RX	CEFTAZIDIME (6GM/VIAL)	INJECTION	False	AP	1992-02-03	CEFTAZIDIME
5	ANDA062655_001	discontinued	CEFTAZIDIME (1GM/VIAL)	INJECTION	False		1985-11-20	TAZIDIME
6	ANDA062655_002	discontinued	CEFTAZIDIME (2GM/VIAL)	INJECTION	False		1985-11-20	TAZIDIME
7	ANDA062662_001	RX	CEFTAZIDIME (500MG/VIAL)	INJECTION	False	AP	1986-03-06	TAZICEF
8	ANDA062662_002	RX	CEFTAZIDIME (1GM/VIAL)	INJECTION	False	AP	1986-03-06	TAZICEF
9	ANDA062662_003	RX	CEFTAZIDIME (2GM/VIAL)	INJECTION	False	AP	1986-03-06	TAZICEF
10	ANDA062662_004	RX	CEFTAZIDIME (6GM/VIAL)	INJECTION	False	AP	1986-03-06	TAZICEF
11	ANDA062739_001	discontinued	CEFTAZIDIME (1GM/VIAL)	INJECTION	False		1986-07-10	TAZIDIME IN PLASTIC CONTAINER
12	ANDA062739_002	discontinued	CEFTAZIDIME (2GM/VIAL)	INJECTION	False		1986-07-10	TAZIDIME IN PLASTIC CONTAINER
13	ANDA063221_001	discontinued	CEFTAZIDIME SODIUM (EQ 10MG BASE/ML)	INJECTION	False		1993-04-29	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
14	ANDA063221_002	discontinued	CEFTAZIDIME SODIUM (EQ 20MG BASE/ML)	INJECTION	False		1993-04-29	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
15	ANDA063221_003	discontinued	CEFTAZIDIME SODIUM (EQ 40MG BASE/ML)	INJECTION	False		1993-04-29	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
16	ANDA063322_001	discontinued	CEFTAZIDIME (1GM/VIAL)	INJECTION	False		1995-11-07	PENTACEF
17	ANDA063322_002	discontinued	CEFTAZIDIME (2GM/VIAL)	INJECTION	False		1995-11-07	PENTACEF
18	ANDA064006_001	discontinued	CEFTAZIDIME (1GM/VIAL)	INJECTION	False		1992-03-31	PENTACEF
19	ANDA064006_002	discontinued	CEFTAZIDIME (2GM/VIAL)	INJECTION	False		1992-03-31	PENTACEF
20	ANDA064008_001	discontinued	CEFTAZIDIME (6GM/VIAL)	INJECTION	False		1992-03-31	PENTACEF
21	ANDA064008_002	discontinued	CEFTAZIDIME (10GM/VIAL)	INJECTION	False		1992-03-31	PENTACEF
22	ANDA064032_001	RX	CEFTAZIDIME (1GM/VIAL)	INJECTION	False	AP	1993-10-31	TAZICEF
23	ANDA064032_002	RX	CEFTAZIDIME (2GM/VIAL)	INJECTION	False	AP	1993-10-31	TAZICEF
24	ANDA065196_001	RX	CEFTAZIDIME (1GM/VIAL)	INJECTION	False	AP	2008-10-15	CEFTAZIDIME
25	ANDA065481_001	discontinued	CEFTAZIDIME (500MG/VIAL)	INJECTION	False		2010-05-28	CEFTAZIDIME
26	ANDA065481_002	discontinued	CEFTAZIDIME (1GM/VIAL)	INJECTION	False		2010-05-28	CEFTAZIDIME
27	ANDA065481_003	discontinued	CEFTAZIDIME (2GM/VIAL)	INJECTION	False		2010-05-28	CEFTAZIDIME
28	ANDA065482_001	discontinued	CEFTAZIDIME (6GM/VIAL)	INJECTION	False		2010-05-28	CEFTAZIDIME
29	NDA050578_001	RX	CEFTAZIDIME (500MG/VIAL)	INJECTION	True	AP	1985-07-19	FORTAZ
30	NDA050578_002	RX	CEFTAZIDIME (1GM/VIAL)	INJECTION	True	AP	1985-07-19	FORTAZ
31	NDA050578_003	RX	CEFTAZIDIME (2GM/VIAL)	INJECTION	True	AP	1985-07-19	FORTAZ
32	NDA050578_004	RX	CEFTAZIDIME (6GM/VIAL)	INJECTION	True	AP	1985-07-19	FORTAZ
33	NDA050634_001	discontinued	CEFTAZIDIME SODIUM (EQ 10MG BASE/ML)	INJECTION	False		1989-04-28	FORTAZ IN PLASTIC CONTAINER
34	NDA050634_002	RX	CEFTAZIDIME SODIUM (EQ 20MG BASE/ML)	INJECTION	True		1989-04-28	FORTAZ IN PLASTIC CONTAINER
35	NDA050634_003	RX	CEFTAZIDIME SODIUM (EQ 40MG BASE/ML)	INJECTION	True		1989-04-28	FORTAZ IN PLASTIC CONTAINER
36	NDA050646_001	discontinued	CEFTAZIDIME (500MG/VIAL)	INJECTION	False		1990-09-27	CEPTAZ
37	NDA050646_002	discontinued	CEFTAZIDIME (1GM/VIAL)	INJECTION	False		1990-09-27	CEPTAZ
38	NDA050646_003	discontinued	CEFTAZIDIME (2GM/VIAL)	INJECTION	False		1990-09-27	CEPTAZ
39	NDA050646_004	discontinued	CEFTAZIDIME (10GM/VIAL)	INJECTION	False		1990-09-27	CEPTAZ
40	NDA050823_001	RX	CEFTAZIDIME (EQ 1GM BASE)	INJECTION	False		2011-06-13	CEFTAZIDIME IN DEXTROSE CONTAINER
41	NDA050823_002	RX	CEFTAZIDIME (EQ 2GM BASE)	INJECTION	True		2011-06-13	CEFTAZIDIME IN DEXTROSE CONTAINER

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)	in other drug docs
1	112c5457-8d71-49f5-b531-9761d7d38c93 (view SPL)	Ceftazidime for Injection, USP	prescription	Human Prescription	Sagent Pharmaceuticals		2015-01-08	6	250210127, 250210128
2	1b41f272-0727-4ce5-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: 1985	prescription	Human Prescription	B. Braun Medical Inc.		2015-05-29	11	002643143, 002643145
3	40d48c5d-650e-461b-a67b-7e65772d1b92 (view SPL)	PRESCRIBING INFORMATIONRx only TAZICEF brand of ceftazidime for injection, USP	prescription	Human Prescription	Hospira, Inc.		2014-10-27	2	004095082, 004095084
4	757c31dc-99ef-4960-b118-738b79631b1a (view SPL)	Ceftazidime for Injection, USP	prescription	Human Prescription	Sandoz Inc		2015-07-27	12	007813177, 007813178
5	981b9abe-4c76-41b2-8f36-eb3e28fa5adc (view SPL)	FORTAZ (ceftazidime for injection)FORTAZ (ceftazidime injection)	prescription	Human Prescription	Covis Pharmaceuticals, Inc.	MANUFACTURE, PACK	2014-10-08	5	249870377, 249870378, 249870379, 249870412, 249870413, 249870382, 249870434, 249870435	Ceftazidime Injectable Solution
6	9b73979c-c95a-4433-0a9d-f9cea3cb557f (view SPL)	PRESCRIBING INFORMATIONTAZICEF Rx only	prescription	Human Prescription	Hospira, Inc.		2014-10-27	14	004095092, 004095093
7	bcc81df2-20e3-4738-bfcf-301da883c1d9 (view SPL)	Ceftazidime for Injection	prescription	Human Prescription	Wg Critical Care, Llc		2015-01-22	2	445670235, 445670236
8	bfd92fd8-3014-44dd-b69b-4276262a51fa (view SPL)	Ceftazidime for Injection, USPFor Intravenous or Intramuscular Use	prescription	Human Prescription	Sagent Pharmaceuticals		2015-03-13	2	250210127, 250210128
9	fd2fa2af-5929-4152-afd3-55e4e162f765 (view SPL)	FORTAZ (ceftazidime for injection)FORTAZ (ceftazidime injection)	prescription	Human Prescription	Cardinal Health	REPACK	2011-06-13	1	551541125

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