Application 050596

Type: NDA
Sponsor: US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	No
002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	No
003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No
004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20
N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20
N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20
N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20

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 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-02-18 07:12 UTC	2024-02	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`f41ea6bd6efb…`

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
17915	SUPPL	2015-04-14
30142	SUPPL	2015-03-24
30141	SUPPL	2014-02-25
17914	SUPPL	2014-02-25
39023	SUPPL	2011-09-16
7867	SUPPL	2011-09-13
7866	SUPPL	2009-06-02
39022	SUPPL	2008-02-25
7865	SUPPL	2008-02-25
30140	SUPPL	2004-06-24
7864	SUPPL	2002-01-18