Application 091031

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOTETAN	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
002	CEFOTETAN	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 2GM 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091031-001	CEFOTETAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2011-10-26
A091031-002	CEFOTETAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2011-10-26

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2011-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091031-001	CEFOTETAN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091031-002	CEFOTETAN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091031-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091031-002	AP	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A091031-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091031-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091031-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091031-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091031-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091031-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091031-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091031-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091031-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091031-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091031-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091031-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091031-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091031-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091031-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091031-002	AP	1	`ea99ee380514…`

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	Hikma Pharmaceuticals USA Inc.	33b13b93-58ce-44c7-b9a2-af3b3a333f80	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091031 application number: ANDA091031 ndc (product): 0143-9670 ndc (product): 0143-9671

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9670	Cefotetan	Cefotetan	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9670	Cefotetan	Cefotetan	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9671	Cefotetan	Cefotetan	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9671	Cefotetan	Cefotetan	West-Ward Pharmaceuticals Corp	ANDA	Current