Application 050558

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ZINACEF	CEFUROXIME SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 750MG BASE/VIAL	Yes	Yes
003	ZINACEF	CEFUROXIME SODIUM	INJECTABLE;INJECTION	EQ 1.5GM BASE/VIAL	Yes	Yes
004	ZINACEF	CEFUROXIME SODIUM	INJECTABLE;INJECTION	EQ 7.5GM BASE/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050558-002	ZINACEF	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	RLD	1983-10-19
N050558-003	ZINACEF	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-10-19
N050558-004	ZINACEF	CEFUROXIME SODIUM	EQ 7.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-10-23

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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RLD	1983-10-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1983-10-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1986-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RLD	1983-10-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1983-10-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1986-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RLD	1983-10-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1983-10-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1986-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RLD	1983-10-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1983-10-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1986-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RLD	1983-10-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1983-10-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1986-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS		RLD	1983-10-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1983-10-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1986-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050558-002	ZINACEF	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RLD, RS	1983-10-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050558-003	ZINACEF	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1983-10-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050558-004	ZINACEF	EQ 7.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-10-23	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	N050558-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050558-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050558-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050558-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050558-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050558-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050558-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050558-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050558-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050558-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050558-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050558-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050558-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050558-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050558-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050558-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050558-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050558-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050558-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050558-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050558-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050558-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050558-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050558-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050558-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050558-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050558-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050558-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050558-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050558-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050558-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050558-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050558-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050558-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050558-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050558-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050558-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050558-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050558-004	AP	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050558-002	AB	1	`3f0d92c62455…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime sodium	CEFUROXIME SODIUM	Sagent Pharmaceuticals	0a145288-733a-4966-b7ae-dc96eb103d8c	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67539	SUPPL	2021-05-18
67529	SUPPL	2021-05-18
67509	SUPPL	2021-05-17
61871	SUPPL	2020-02-12
61867	SUPPL	2020-02-12
17873	SUPPL	2014-09-30
7815	SUPPL	2014-09-29
38981	SUPPL	2007-07-31
30080	SUPPL	2007-07-31
17872	SUPPL	2004-05-27
30079	SUPPL	2004-05-26
38980	SUPPL	2003-05-02