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 1 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
2026-10-15 13:18:30	2026-09	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062422-005	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062422-006	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1991-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062422-001	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062422-002	CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062422-003	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062422-004	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-01-31	`fd3edfee7708…`

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)#