Application 065323

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	No	No
002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	No	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
A065323-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL			2008-02-05
A065323-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL			2008-02-05

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065323-001	CEFUROXIME AXETIL	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065323-002	CEFUROXIME AXETIL	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2008-02-05	`4b0b4de00fa7…`

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 brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Coupler LLC	2c3a502f-8e72-c4d2-e063-6394a90a6fa5	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil 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 brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	83476d51-be74-748b-e053-2a91aa0a3d36	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	8c3c1c85-cbce-66e2-e053-2a95a90a94fe	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	NorthStar Rx LLC	fd79c41e-b0e9-47dc-a3ce-caacdc66bc96	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Aurobindo Pharma Limited	faef39e9-d793-4191-a728-310f6fab759d	2024-04-29	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil 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 brand name: Cefuroxime Axetil 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 brand name: Cefuroxime Axetil 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 brand name: Cefuroxime axetil 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 brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Proficient Rx LP	e9a020ec-e446-469a-b1d1-07e82eefa305	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-963	Cefuroxime Axetil For Oral Suspension	Cefuroxime Axetil	Ranbaxy Pharmaceuticals Inc	ANDA	Current
63304-964	Cefuroxime Axetil For Oral Suspension	Cefuroxime Axetil	Ranbaxy Pharmaceuticals Inc	ANDA	Current