Home Applications 065166 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 RLD / RS 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.
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 RLD / RS 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# 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 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
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