Application 203704

Type: ANDA
Sponsor: QILU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203704-001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01
A203704-002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01
A203704-003	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203704-002	AP
A203704-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A203704-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203704-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203704-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203704-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203704-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203704-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203704-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203704-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203704-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203704-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203704-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203704-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203704-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203704-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203704-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203704-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203704-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203704-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203704-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203704-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203704-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203704-001	AP	1	`74a2ff9319b5…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefepime	CEFEPIME	Apotex Corp.	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704 ndc (product): 60505-6144 ndc (product): 60505-6145
Cefepime	CEFEPIME	Apotex Corp.	02aa374f-37b4-456a-b5de-cfd3bbb6ce6e	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704 ndc (product): 60505-6245 ndc (product): 60505-6246
Cefepime	CEFEPIME	Apotex Corp.	dd641c7f-b857-48ff-bd9d-747e0c3cc89f	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704 ndc (product): 60505-6147 ndc (product): 60505-6146
Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	80b4c811-4a71-47fb-8565-85ce9d0f782c	2021-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704 ndc (product): 67184-1004 ndc (product): 67184-1002 ndc (product): 67184-1003

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
60505-6144	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6144	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6144	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6144	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6145	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6145	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6145	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6145	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6146	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6146	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6146	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6147	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6147	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6147	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6245	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
60505-6246	Cefepime	Cefepime	Apotex Corp.	ANDA	Current
67184-1002	Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-1002	Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-1003	Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-1003	Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-1004	Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-1004	Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	ANDA	Current