Application 065415

Type: ANDA
Sponsor: ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOXITIN	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 10GM 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065415-001	CEFOXITIN	CEFOXITIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065415-001	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 2 · 41 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	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065415-001	CEFOXITIN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2010-05-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065415-001	AP	1	`a50c72e98297…`

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
Cefoxitin	CEFOXITIN	WG Critical Care, LLC	f5288962-caee-4771-8229-df9cdefcfa67	2023-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065415 application number: ANDA065415 ndc (product): 44567-247
Cefoxitin	CEFOXITIN	Sagent Pharmaceuticals	4c6f7665-204f-6c69-7669-61204d756e6e	2020-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065415 application number: ANDA065415 ndc (product): 25021-111

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-111	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-111	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
44567-247	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-247	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-247	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
63323-343	Cefoxitin	Cefoxitin	Fresenius Kabi USA, LLC	ANDA	Current
63323-343	Cefoxitin	Cefoxitin	Fresenius Kabi USA, LLC	ANDA	Current