Application 065072

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOTAXIME	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	Yes
002	CEFOTAXIME	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	Yes
003	CEFOTAXIME	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	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	Approval date
A065072-001	CEFOTAXIME	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2002-11-20
A065072-002	CEFOTAXIME	CEFOTAXIME SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2002-11-20
A065072-003	CEFOTAXIME	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2002-11-20

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 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	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2002-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2002-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2002-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2002-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2002-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2002-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2002-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065072-001	CEFOTAXIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065072-002	CEFOTAXIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065072-003	CEFOTAXIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		RS	2002-11-20	`3a93d1ddd44b…`

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	A065072-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065072-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065072-003	AP	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A065072-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065072-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065072-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065072-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065072-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065072-003	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefotaxime	CEFOTAXIME	Hikma Pharmaceuticals USA Inc.	ed23b6bc-32c7-4c50-a53d-313ae78e5623	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065072 application number: ANDA065072 ndc (product): 0143-9931 ndc (product): 0143-9930 ndc (product): 0143-9933

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9930	Cefotaxime	Cefotaxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9930	Cefotaxime	Cefotaxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9931	Cefotaxime	Cefotaxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9931	Cefotaxime	Cefotaxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9933	Cefotaxime	Cefotaxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9933	Cefotaxime	Cefotaxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22309	ORIG	2005-07-22