Application 065303

Type: ANDA
Sponsor: ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065303-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22
A065303-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065303-001	AP
A065303-002	AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065303-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065303-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065303-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065303-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065303-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065303-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065303-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065303-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065303-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065303-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065303-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065303-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065303-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065303-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065303-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065303-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065303-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065303-002	AP	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	WG Critical Care, LLC	00dd6da7-50a8-44c9-b2dc-7948973df392	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065303 application number: ANDA065303 ndc (product): 44567-120
Cefazolin	CEFAZOLIN	WG Critical Care, LLC	f17160d4-fc42-4f9c-abb8-d04f01ae6dd1	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065303 application number: ANDA065303 ndc (product): 44567-706 ndc (product): 44567-707
CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	c47c8d14-1eef-40f9-9d11-f0c300b1d4be	2023-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065303 application number: ANDA065303 ndc (product): 63323-237 ndc (product): 63323-236

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-100	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-100	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-100	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-100	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-100	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-100	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-100	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	Cefazolin	Cefazolin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-101	cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
44567-120	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-120	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-120	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-120	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-706	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-706	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-706	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-706	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-706	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-706	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-707	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-707	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-707	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-707	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-707	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-707	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
50090-2238	Cefazolin	Cefazolin	A-S Medication Solutions	ANDA	Current
52584-100	Cefazolin	Cefazolin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-100	Cefazolin	Cefazolin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-100	Cefazolin	Cefazolin	General Injectables and Vaccines, Inc.	ANDA	Current
55154-9559	CEFAZOLIN	CEFAZOLIN SODIUM	Cardinal Health	ANDA	Current
63323-236	CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-236	CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-236	CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-237	CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-237	CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-237	CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	ANDA	Current