Home Applications 065069 Application 065069
Type ANDA
Sponsor APOTEX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFUROXIME AXETIL CEFUROXIME AXETIL TABLET;ORAL EQ 250MG BASE No No 002 CEFUROXIME AXETIL CEFUROXIME AXETIL TABLET;ORAL EQ 500MG BASE No 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 A065069-001 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2002-10-02 A065069-002 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2002-10-02
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2002-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2002-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2002-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2002-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2002-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2002-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2002-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2002-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2002-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2002-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065069-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2002-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065069-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2002-10-02 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
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.