FDA Orange Book · active-ingredient family
Cefuroxime axetil
Cefuroxime axetil: 2 brands, 11 generics; first approved Dec 28, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
11
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- CEFTINRLDGLAXOSMITHKLINENDA 05067219942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFTINRLDGLAXOSMITHKLINENDA 05060519873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET ORAL Discontinued — EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- CEFUROXIME AXETILALKEM LABS LTDANDA 06549620102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB - CEFUROXIME AXETILANDA REPOSITORYANDA 06535920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET ORAL Rx AB EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB - CEFUROXIME AXETILSUN PHARM INDS LTDANDA 06532320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFUROXIME AXETILAUROBINDO PHARMAANDA 06530820063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET ORAL Rx AB EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB - CEFUROXIME AXETILCHARTWELL RXANDA 06516620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET ORAL Rx AB EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB - CEFUROXIME AXETILANI PHARMSANDA 06519020042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - CEFUROXIME AXETILFOSUN PHARMAANDA 06512620032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - CEFUROXIME AXETILLUPINANDA 06513520032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - CEFUROXIME AXETILSUN PHARM INDS LTDANDA 06511820033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET ORAL Discontinued — EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - CEFUROXIME AXETILAPOTEXANDA 06506920022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - CEFUROXIME AXETILRANBAXY LABS LTDANDA 06504320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — EQ 250MG BASE TABLET ORAL Discontinued — EQ 125MG BASE TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
39 yr 2 mo ago
Most recent approval
16 yr 5 mo ago
Approvals span 1987–2010 across 13 FDA applications.
Brand (NDA) 215%
Generic (ANDA) 1185%
Cefuroxime axetil: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
