Application 065441

Type: ANDA
Sponsor: ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2GM 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
A065441-001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-03-20
A065441-002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065441-001	AP
A065441-002	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	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`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	A065441-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065441-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065441-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065441-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065441-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065441-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065441-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065441-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065441-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065441-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065441-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065441-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065441-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065441-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065441-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065441-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065441-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065441-002	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
Cefepime	CEFEPIME	WG Critical Care, LLC	5fd857e5-591f-44ca-80cf-fd903660b03c	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 44567-241 ndc (product): 44567-240
Cefepime	CEFEPIME	WG Critical Care, LLC	c654ef2e-1067-4026-8931-6a0dc2a17ad1	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 44567-130 ndc (product): 44567-131
Cefepime	CEFEPIME	Hospira, Inc.	e80c27e2-164d-4836-ba24-c160d75dc5d3	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 0409-9566 ndc (product): 0409-9735
Cefepime	CEFEPIME	Fresenius Kabi USA, LLC	5e1695e0-1310-4cd8-a5da-ad1a7dcd1792	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 63323-326 ndc (product): 63323-340
cefepime	CEFEPIME HYDROCHLORIDE	Sagent Pharmaceuticals	de477f37-40f6-4295-ae72-a2ee36a8922e	2021-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 25021-121 ndc (product): 25021-122

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
0409-9566	Cefepime	Cefepime	Hospira, Inc.	ANDA	Current
0409-9566	Cefepime	Cefepime	Hospira, Inc.	ANDA	Current
0409-9735	Cefepime	Cefepime	Hospira, Inc.	ANDA	Current
0409-9735	Cefepime	Cefepime	Hospira, Inc.	ANDA	Current
0781-3222	Cefepime Hydrochloride	Cefepime Hydrochloride	Sandoz Inc	ANDA	Current
0781-3223	Cefepime Hydrochloride	Cefepime Hydrochloride	Sandoz Inc	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-121	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-122	cefepime	cefepime hydrochloride	Sagent Pharmaceuticals	ANDA	Current
44567-130	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-130	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-131	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-131	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-240	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-240	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-240	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-240	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-240	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-240	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-241	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-241	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-241	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-241	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-241	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
44567-241	Cefepime	Cefepime	WG Critical Care, LLC	ANDA	Current
63323-326	Cefepime	Cefepime	Fresenius Kabi USA, LLC	ANDA	Current
63323-340	Cefepime	Cefepime	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44240	ORIG	2008-03-21