Application 050817

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFEPIME IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	Yes	Yes
002	CEFEPIME IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	Yes	Yes

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
N050817-001	CEFEPIME IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2008-08-05
N050817-002	CEFEPIME IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2008-08-05

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050817-001	CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050817-002	CEFEPIME IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2008-08-05	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefepime	CEFEPIME	Baxter Healthcare Corporation	be5f8ca6-7232-423a-a2d5-cccb7abe7921	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050817 application number: NDA050817 ndc (product): 0338-1301

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-1301	Cefepime	cefepime	Baxter Healthcare Corporation	NDA	Current
0338-1301	Cefepime	cefepime	Baxter Healthcare Corporation	NDA	Current
0338-1301	Cefepime	cefepime	Baxter Healthcare Corporation	NDA	Current
0338-1301	Cefepime	cefepime	Baxter Healthcare Corporation	NDA	Current
0338-1301	Cefepime	cefepime	Baxter Healthcare Corporation	NDA	Current
0338-1301	Cefepime	cefepime	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82994	SUPPL	2025-07-31
82987	SUPPL	2025-07-30
62820	SUPPL	2020-05-05
62814	SUPPL	2020-05-04
39384	SUPPL	2016-05-11
30607	SUPPL	2016-05-10
39383	SUPPL	2014-06-10
8337	SUPPL	2014-06-05
18296	SUPPL	2012-09-11
8338	SUPPL	2012-09-10
18295	SUPPL	2010-07-06
30606	SUPPL	2010-07-02
44789	ORIG	2009-12-31
42752	ORIG	2009-12-31
23729	ORIG	2008-09-19
30605	ORIG	2008-08-12