Application 065197

Type: ANDA
Sponsor: WOCKHARDT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOTAXIME	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
002	CEFOTAXIME SODIUM	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
003	CEFOTAXIME SODIUM	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A065197-001	CEFOTAXIME	CEFOTAXIME SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29
A065197-002	CEFOTAXIME SODIUM	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20
A065197-003	CEFOTAXIME SODIUM	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065197-002	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065197-003	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2008-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065197-001	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2006-08-29	`301d65b070ca…`

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	A065197-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065197-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065197-003	AP	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A065197-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065197-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065197-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065197-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065197-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065197-003	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefotaxime	CEFOTAXIME INJECTION	SteriMax Inc.	8efe3bd0-c43a-2bd6-e053-2a95a90a92fa	2026-06-15		Name fallback brand name: Cefotaxime
Cefotaxime	CEFOTAXIME	Hikma Pharmaceuticals USA Inc.	ed23b6bc-32c7-4c50-a53d-313ae78e5623	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Cefotaxime
Cefotaxime	CEFOTAXIME	Hikma Pharmaceuticals USA Inc.	ef1a6dc6-bc3d-4f09-8f92-7ff328f56561	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Cefotaxime

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55648-947	CEFOTAXIME	CEFOTAXIME	WOCKHARDT LIMITED	ANDA	Current
55648-948	CEFOTAXIME	CEFOTAXIME	WOCKHARDT LIMITED	ANDA	Current
55648-986	CEFOTAXIME	CEFOTAXIME	WOCKHARDT LIMITED	ANDA	Current
64679-947	Cefotaxime	Cefotaxime	Wockhardt USA LLC.	ANDA	Current
64679-947	Cefotaxime	Cefotaxime	Wockhardt USA LLC.	ANDA	Current
64679-948	Cefotaxime	Cefotaxime	Wockhardt USA LLC.	ANDA	Current
64679-948	Cefotaxime	Cefotaxime	Wockhardt USA LLC.	ANDA	Current
64679-986	Cefotaxime	Cefotaxime	Wockhardt USA LLC.	ANDA	Current
64679-986	Cefotaxime	Cefotaxime	Wockhardt USA LLC.	ANDA	Current