Application 065306

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 10GM BASE/VIAL	No	No
002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	No	Yes

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
A065306-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22
A065306-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065306-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065306-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065306-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065306-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065306-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065306-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065306-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065306-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065306-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065306-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065306-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065306-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065306-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065306-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065306-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065306-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065306-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065306-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065306-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065306-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065306-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065306-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065306-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065306-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065306-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065306-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065306-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065306-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065306-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065306-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065306-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065306-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065306-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065306-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065306-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065306-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065306-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065306-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065306-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065306-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065306-001	AP	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	WG Critical Care, LLC	1999084a-124c-45f9-801f-416a1b942c96	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065306 application number: ANDA065306 ndc (product): 44567-708
Cefazolin	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	47a8928f-708d-418a-829b-36eded96bac0	2020-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065306 application number: ANDA065306 ndc (product): 63323-238 ndc (product): 63323-449

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-102	Cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-102	Cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-102	Cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-102	Cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-102	Cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
25021-102	Cefazolin	cefazolin sodium	Sagent Pharmaceuticals	ANDA	Current
44567-708	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-708	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-708	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
44567-708	Cefazolin	Cefazolin	WG Critical Care, LLC	ANDA	Current
63323-238	Cefazolin	Cefazolin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-238	Cefazolin	Cefazolin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-238	Cefazolin	Cefazolin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-449	Cefazolin	Cefazolin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-449	Cefazolin	Cefazolin Sodium	Fresenius Kabi USA, LLC	ANDA	Current