Application 065166

Type: ANDA
Sponsor: WOCKHARDT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 125MG BASE	No	No
002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 250MG BASE	No	No
003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 500MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A065166-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29
A065166-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29
A065166-003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065166-001	AB
A065166-002	AB
A065166-003	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A065166-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065166-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065166-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Redpharm Drug	56cb6f42-9ae1-38e7-e063-6294a90a3feb	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil 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 brand name: Cefuroxime Axetil 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 brand name: Cefuroxime Axetil 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 brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	4e4426a4-0ca9-dad5-e063-6294a90a5fdb	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil 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 brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	REMEDYREPACK INC.	76cec54f-d167-4298-951b-5411a3c47f4a	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil 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 brand name: Cefuroxime Axetil 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 brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Redpharm Drug	3744f28c-c7e1-259c-e063-6294a90a10ed	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil 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 brand name: Cefuroxime axetil 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 brand name: Cefuroxime axetil 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 brand name: Cefuroxime Axetil 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 brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Ascend Laboratories, LLC	dd11e4b9-7730-4d3a-81ca-16f15de09759	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	3f92c452-18b4-5af8-e063-6394a90aaa53	2025-09-24	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Major Pharmaceuticals	44e1fb4d-4b61-40da-9974-0bd2006eb828	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	American Health Packaging	f38418a7-dd90-4f20-b747-7ac086c53015	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Preferred Pharmaceuticals Inc.	bc9200d2-4a6d-4847-ba85-8e9d378390de	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil 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 brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55289-385	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-385	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-385	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-385	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55648-920	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt Limited	ANDA	Current
55648-921	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt Limited	ANDA	Current
55648-922	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt Limited	ANDA	Current
64679-920	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt USA LLC.	ANDA	Current
64679-920	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt USA LLC.	ANDA	Current
64679-921	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt USA LLC.	ANDA	Current
64679-921	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt USA LLC.	ANDA	Current
64679-922	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt USA LLC.	ANDA	Current
64679-922	Cefuroxime Axetil	Cefuroxime Axetil	Wockhardt USA LLC.	ANDA	Current
68788-9333	Cefuroxime Axetil	Cefuroxime Axetil	Preferred Pharmaceuticals, Inc.	ANDA	Current