Application 050589

Type: NDA
Sponsor: ASTELLAS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03
N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03
N050589-003	CEFIZOX IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13
N050589-004	CEFIZOX IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`d06236e962d9…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7857	SUPPL	2005-01-21

Application 050589

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Documents#