Application 050578

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	500MG/VIAL	Yes	Yes
002	FORTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	1GM/VIAL	Yes	Yes
003	FORTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	2GM/VIAL	Yes	Yes
004	FORTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	6GM/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050578-001	FORTAZ	CEFTAZIDIME	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-07-19
N050578-002	FORTAZ	CEFTAZIDIME	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-07-19
N050578-003	FORTAZ	CEFTAZIDIME	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-07-19
N050578-004	FORTAZ	CEFTAZIDIME	6GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-07-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050578-001	FORTAZ	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050578-002	FORTAZ	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050578-003	FORTAZ	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050578-004	FORTAZ	6GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050578-001	FORTAZ	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050578-002	FORTAZ	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050578-003	FORTAZ	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050578-004	FORTAZ	6GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050578-001	FORTAZ	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050578-002	FORTAZ	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050578-003	FORTAZ	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050578-004	FORTAZ	6GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION		RLD	1985-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050578-001	FORTAZ	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050578-002	FORTAZ	1GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050578-003	FORTAZ	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050578-004	FORTAZ	6GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-19	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050578-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050578-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050578-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050578-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050578-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050578-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050578-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050578-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050578-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050578-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050578-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050578-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050578-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050578-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050578-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050578-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050578-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050578-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050578-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050578-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050578-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050578-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050578-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050578-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050578-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050578-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050578-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050578-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050578-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050578-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050578-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050578-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050578-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050578-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050578-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050578-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050578-004	AP	1	`c0c555d07b60…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	112c5457-8d71-49f5-b531-9761d7d38c93	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
TAZICEF	CEFTAZIDIME	Hospira, Inc.	40d48c5d-650e-461b-a67b-7e65772d1b92	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
TAZICEF	CEFTAZIDIME	Hospira, Inc.	1ab5ae3e-e303-4499-4c89-472d7cc1e46c	2024-07-04	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	aec64360-8452-4987-a366-a5a4f8762ab6	2024-01-03	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
Ceftazidime	CEFTAZIDIME	WG Critical Care, LLC	bcc81df2-20e3-4738-bfcf-301da883c1d9	2023-09-11	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-105	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-105	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-106	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-106	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-107	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-107	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-109	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-109	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-110	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current
52565-111	FORTAZ	ceftazidime	Teligent Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61881	SUPPL	2020-02-13
61880	SUPPL	2020-02-13
61872	SUPPL	2020-02-12
61870	SUPPL	2020-02-12
57689	ORIG	2019-02-15
49190	SUPPL	2017-08-02
49161	SUPPL	2017-07-31
30108	SUPPL	2014-09-26
17894	SUPPL	2014-09-26
7837	SUPPL	2007-07-16
17893	SUPPL	2007-07-10
38998	SUPPL	2007-03-15
38997	SUPPL	2004-05-27
30107	SUPPL	2004-05-26
17892	SUPPL	2002-03-29
7836	SUPPL	2002-03-29
30106	SUPPL	2002-03-22