Application 050694

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOTAN IN PLASTIC CONTAINER	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No
002	CEFOTAN IN PLASTIC CONTAINER	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050694-001	CEFOTAN IN PLASTIC CONTAINER	CEFOTETAN DISODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION			1993-07-30
N050694-002	CEFOTAN IN PLASTIC CONTAINER	CEFOTETAN DISODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION			1993-07-30

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 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050694-001	CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050694-002	CEFOTAN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1993-07-30	`4b0b4de00fa7…`

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
Cefotetan	CEFOTETAN DISODIUM	Fresenius Kabi USA, LLC	bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: CEFOTETAN DISODIUM

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
22191	ORIG	1999-03-04