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 44.

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050589-001	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050589-002	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1984-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050589-003	CEFIZOX IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050589-004	CEFIZOX IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	1995-04-13	`4b0b4de00fa7…`

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
7857	SUPPL	2005-01-21