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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050672-001	CEFTIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1994-06-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050672-002	CEFTIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1997-04-29	`3a93d1ddd44b…`

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime Axetil	CEFUROXIME AXETIL	REMEDYREPACK INC.	76cec54f-d167-4298-951b-5411a3c47f4a	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Redpharm Drug	56cb6f42-9ae1-38e7-e063-6294a90a3feb	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	85cdd8d9-557e-4d15-855a-027e7809cf64	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	d14d4184-3e29-43cd-8046-658699c70f03	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Golden State Medical Supply, Inc.	bb7955fe-5111-1662-e053-2a95a90a85a1	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	4e4426a4-0ca9-dad5-e063-6294a90a5fdb	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	a84ac4ed-c268-4e9f-9df8-256e0a64cd16	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	a940ba01-2b53-4947-9019-d3d8f4e9ad80	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Advanced Rx of Tennessee, LLC	48d96608-d3da-b512-e063-6294a90a07d5	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Redpharm Drug	3744f28c-c7e1-259c-e063-6294a90a10ed	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af8f061-c0e1-3a1c-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af94304-8118-41c7-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	aa6685c1-51ed-466a-ae7f-89a82986a7b1	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	119c4d09-2324-498f-9318-1f8db49ad4b6	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Ascend Laboratories, LLC	dd11e4b9-7730-4d3a-81ca-16f15de09759	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	3f92c452-18b4-5af8-e063-6394a90aaa53	2025-09-24	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Major Pharmaceuticals	44e1fb4d-4b61-40da-9974-0bd2006eb828	2025-09-12	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	American Health Packaging	f38418a7-dd90-4f20-b747-7ac086c53015	2025-08-06	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Preferred Pharmaceuticals Inc.	bc9200d2-4a6d-4847-ba85-8e9d378390de	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	15cabe73-f39d-4798-a840-115fe94f8f96	2025-03-13	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