Application 061773

Type: ANDA
Sponsor: ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEFZOL	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No
002	KEFZOL	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
003	KEFZOL	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
004	KEFZOL	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No
005	KEFZOL	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A061773-001	KEFZOL	CEFAZOLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A061773-002	KEFZOL	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A061773-003	KEFZOL	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A061773-004	KEFZOL	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A061773-005	KEFZOL	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08

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 4 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061773-001	KEFZOL	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061773-002	KEFZOL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061773-003	KEFZOL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061773-004	KEFZOL	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061773-005	KEFZOL	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		1987-09-08	`1c564ffb4f44…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin Sodium	CEFAZOLIN SODIUM	B. Braun Medical Inc.	17f8f038-c204-4dab-80d7-6f7ac41ddbec	2025-03-10	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	cf13db9c-d8a1-489f-9aa0-fc70839d4bbc	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin Sodium	CEFAZOLIN SODIUM	Direct_rx	22dfc2e4-07a7-8d13-e063-6394a90a3e9f	2024-09-24	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	c47c8d14-1eef-40f9-9d11-f0c300b1d4be	2023-09-27	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	47a8928f-708d-418a-829b-36eded96bac0	2020-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM

Reported adverse events (FAERS/openFDA)#

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