Application 062422

Type: ANDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	No
002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No
003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	No
004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No
005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	No
006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31
A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31
A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31
A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31
A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16
A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	CEPHALOTHIN SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16

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 2 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Application 062422

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#