Application 050605

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTIN	CEFUROXIME AXETIL	TABLET;ORAL	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CEFTIN	CEFUROXIME AXETIL	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CEFTIN	CEFUROXIME AXETIL	TABLET;ORAL	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N050605-001	CEFTIN	CEFUROXIME AXETIL	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28
N050605-002	CEFTIN	CEFUROXIME AXETIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28
N050605-003	CEFTIN	CEFUROXIME AXETIL	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050605-002	CEFTIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050605-003	CEFTIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050605-001	CEFTIN	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-28	`301d65b070ca…`

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime Axetil	CEFUROXIME AXETIL	Coupler LLC	2c619a79-6b69-b9fa-e063-6394a90a8f27	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Coupler LLC	2c3a502f-8e72-c4d2-e063-6394a90a6fa5	2025-01-21	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	A-S Medication Solutions	84593261-838c-433a-8d9d-1d37b11058da	2024-09-11	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	83476d51-be74-748b-e053-2a91aa0a3d36	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	8c3c1c85-cbce-66e2-e053-2a95a90a94fe	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	NorthStar Rx LLC	fd79c41e-b0e9-47dc-a3ce-caacdc66bc96	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Aurobindo Pharma Limited	faef39e9-d793-4191-a728-310f6fab759d	2024-04-29	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Rising Pharma Holdings, Inc.	66f8d37f-aebc-4435-af80-dfd7b3770088	2024-04-29	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	eb180b38-f8c8-4dbf-856a-347d3ebac857	2024-02-27	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	A-S Medication Solutions	c89e8f4d-96c0-44c6-906a-b803141920b1	2024-02-13	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	bcf7870a-7e45-4ae1-a9b4-457e4781886a	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Proficient Rx LP	e9a020ec-e446-469a-b1d1-07e82eefa305	2023-07-01	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66686	SUPPL	2021-03-09
66662	SUPPL	2021-03-09
58451	SUPPL	2019-04-26
58434	SUPPL	2019-04-26
50086	SUPPL	2017-10-18
50071	SUPPL	2017-10-17
45977	SUPPL	2016-12-01
45950	SUPPL	2016-11-23
30156	SUPPL	2015-08-28
17922	SUPPL	2015-08-27
30155	SUPPL	2015-07-07
39033	SUPPL	2015-07-01
30154	SUPPL	2014-09-23
30153	SUPPL	2014-09-23
39032	SUPPL	2014-09-22
39031	SUPPL	2014-09-22
30152	SUPPL	2007-07-27
17921	SUPPL	2007-07-24
30151	SUPPL	2004-06-07
17920	SUPPL	2004-06-07
7876	SUPPL	2002-07-24
17919	SUPPL	2002-04-11
7875	SUPPL	2002-04-11
17918	SUPPL	2002-03-29
7874	SUPPL	2002-03-29
30150	SUPPL	1999-08-24
22166	SUPPL	1999-08-24