Application 050672

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTIN	CEFUROXIME AXETIL	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	Yes	No
002	CEFTIN	CEFUROXIME AXETIL	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	Yes	No

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

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
N050672-001	CEFTIN	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	1994-06-30
N050672-002	CEFTIN	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	1997-04-29

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 · 86 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	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`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 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
66687	SUPPL	2021-03-09
66663	SUPPL	2021-03-09
58435	SUPPL	2019-04-26
50085	SUPPL	2017-10-18
50072	SUPPL	2017-10-17
45976	SUPPL	2016-12-01
45951	SUPPL	2016-11-23
30257	SUPPL	2015-08-28
18002	SUPPL	2015-08-27
30256	SUPPL	2015-07-07
39091	SUPPL	2015-07-01
30255	SUPPL	2014-09-23
30254	SUPPL	2014-09-23
39090	SUPPL	2014-09-22
39089	SUPPL	2014-09-22
39088	SUPPL	2007-08-02
7968	SUPPL	2007-08-02
39087	SUPPL	2004-06-07
30253	SUPPL	2004-06-07
30252	SUPPL	2002-04-11
18001	SUPPL	2002-04-11
18000	SUPPL	2002-03-29
7967	SUPPL	2002-03-29
30251	SUPPL	1999-08-24
22176	SUPPL	1999-08-24