Application 065414

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 1GM BASE/VIAL	No	Yes
002	CEFOXITIN	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 2GM 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
A065414-001	CEFOXITIN	CEFOXITIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12
A065414-002	CEFOXITIN	CEFOXITIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065414-001	AP
A065414-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`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	A065414-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065414-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065414-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065414-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065414-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065414-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065414-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065414-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065414-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065414-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065414-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065414-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065414-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065414-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065414-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065414-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065414-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065414-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefoxitin	CEFOXITIN	WG Critical Care, LLC	91ac4c14-8dd8-4efe-a462-d1c488a6184f	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414 ndc (product): 44567-245 ndc (product): 44567-246
Cefoxitin	CEFOXITIN	Sagent Pharmaceuticals	b272ef9c-4d83-4ee2-b9cc-477440822cca	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414 ndc (product): 25021-109 ndc (product): 25021-110
Cefoxitin	CEFOXITIN	WG Critical Care, LLC	658a0dc6-6da5-44dc-94f2-1211619297f7	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414 ndc (product): 44567-245 ndc (product): 44567-246
Cefoxitin	CEFOXITIN SODIUM	Fresenius Kabi USA, LLC	2a9d1e7b-96ee-4e6c-a1e8-47b76b924422	2023-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414 ndc (product): 63323-341 ndc (product): 63323-342
Cefoxitin	CEFOXITIN SODIUM	Fresenius Kabi USA, LLC	d02170ff-65aa-48b8-a922-94271c46ffa7	2022-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414 ndc (product): 63323-341 ndc (product): 63323-342

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-109	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-109	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-109	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-109	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-110	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-110	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-110	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
25021-110	Cefoxitin	cefoxitin	Sagent Pharmaceuticals	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-245	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
44567-246	Cefoxitin	Cefoxitin	WG Critical Care, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-341	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-342	Cefoxitin	Cefoxitin Sodium	Fresenius Kabi USA, LLC	ANDA	Current