Application 091048

Type: ANDA
Sponsor: SAGENT PHARMS INC

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 42.

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
A091048-001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2017-01-04
A091048-002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2017-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091048-001	AP
A091048-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091048-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091048-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2017-01-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091048-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091048-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091048-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091048-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091048-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091048-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091048-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091048-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091048-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091048-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091048-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091048-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091048-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091048-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091048-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091048-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091048-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091048-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091048-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091048-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091048-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091048-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091048-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091048-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091048-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091048-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091048-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091048-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091048-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091048-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091048-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091048-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091048-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091048-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091048-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091048-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091048-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091048-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091048-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091048-002	AP	1	`bb7c543d1eb4…`

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 HYDROCHLORIDE AND DEXTROSE	CEFEPIME HYDROCHLORIDE	B. Braun Medical Inc.	57517a0e-ec1b-4605-a7cc-7e3801158ec9	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE
Cefepime Hydrochloride	CEFEPIME HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a01	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Cefepime Hydrochloride generic name: CEFEPIME HYDROCHLORIDE
Cefepime Hydrochloride	CEFEPIME HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	f64c181e-28c5-48ab-aa67-5ca0e3fd079c	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: Cefepime Hydrochloride generic name: CEFEPIME HYDROCHLORIDE
Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	80b4c811-4a71-47fb-8565-85ce9d0f782c	2021-11-15	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE
cefepime	CEFEPIME HYDROCHLORIDE	Sagent Pharmaceuticals	de477f37-40f6-4295-ae72-a2ee36a8922e	2021-09-29	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-209	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
66794-210	Cefepime	Cefepime	Piramal Critical Care Inc.	ANDA	Current
71288-008	Cefepime	cefepime hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-008	Cefepime	cefepime hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-008	Cefepime	cefepime hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-009	Cefepime	cefepime hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-009	Cefepime	cefepime hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-009	Cefepime	cefepime hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current