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 3 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
2022-03-09 01:35 UTC	2022-03	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050596-001	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050596-002	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050596-003	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050596-004	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1985-05-20	`6a51e52b5d6a…`

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