Cefpodoxime proxetil
Cefpodoxime proxetil: 4 brands, 8 generics; first approved Aug 07, 1992; generic available.
Generic available: 8 ANDA applications approved.
Brand (NDA) products
- VANTINRLDPFIZERNDA 05067519922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/5ML FOR SUSPENSION ORAL Discontinued - EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued - - VANTINRLDPFIZERNDA 05067419922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 200MG BASE TABLET ORAL Discontinued - - SANKYONDA 05068819922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued - EQ 50MG BASE/5ML FOR SUSPENSION ORAL Discontinued - - SANKYONDA 05068719922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 200MG BASE TABLET ORAL Discontinued -
Generic (ANDA) products (8)
- CEFPODOXIME PROXETILALKEM LABS LTDANDA 21056820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 200MG BASE TABLET ORAL Rx AB - CEFPODOXIME PROXETILCHARTWELL RXANDA 09003120092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/5ML FOR SUSPENSION ORAL Discontinued - EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued - - CEFPODOXIME PROXETILSANDOZANDA 06546220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 200MG BASE TABLET ORAL Rx AB - CEFPODOXIME PROXETILANDA REPOSITORYANDA 06538820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 200MG BASE TABLET ORAL Rx AB - CEFPODOXIME PROXETILAUROBINDO PHARMAANDA 06537020072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 200MG BASE TABLET ORAL Rx AB - CEFPODOXIME PROXETILAUROBINDO PHARMA LTDANDA 06540920072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/5ML FOR SUSPENSION ORAL Rx - EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx - - CEFPODOXIME PROXETILSUN PHARM INDS LTDANDA 06508320032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 200MG BASE TABLET ORAL Discontinued - - CEFPODOXIME PROXETILSUN PHARM INDS LTDANDA 06508220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/5ML FOR SUSPENSION ORAL Discontinued - EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued -
Listed patents
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
Approvals span 1992โ2022 across 12 FDA applications.
Cefpodoxime proxetil: 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.
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