Application 050588

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOTAN	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	No
002	CEFOTAN	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	Yes	No
003	CEFOTAN	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
N050588-001	CEFOTAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27
N050588-002	CEFOTAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27
N050588-003	CEFOTAN	CEFOTETAN DISODIUM	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050588-001	AP
N050588-002	AP

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050588-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050588-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050588-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050588-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050588-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050588-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050588-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050588-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050588-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050588-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050588-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050588-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050588-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050588-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050588-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050588-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050588-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050588-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050588-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050588-002	AP	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Cefotan	CEFOTETAN	PAI Holdings, LLC dba PAI Pharma	f1510f5e-d001-44e0-accb-27cf79fd4f9a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050588 application number: NDA050588

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-052	Cefotan	Cefotetan Disodium	Teligent Pharma, Inc.	NDA	Current
52565-053	CEFOTAN	cefotetan disodium	Teligent Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57692	ORIG	2019-02-15
47552	SUPPL	2017-03-14
47520	SUPPL	2017-03-10
39014	SUPPL	2004-07-01
30128	SUPPL	2004-07-01
17906	SUPPL	2004-05-28
17907	SUPPL	2003-07-08
7856	SUPPL	2003-07-06
30127	SUPPL	2003-03-10