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FDA Orange Book · active-ingredient family

Cefpodoxime proxetil

Cefpodoxime proxetil: 4 brands, 8 generics; first approved Aug 07, 1992; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 8 ANDA applications approved.

Brands (NDA)
4
Generics (ANDA)
8
Listed patents
0
Presentations
24

Brand (NDA) products

Originator applications
  • NDA 05067519922 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 50MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
    EQ 100MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
  • NDA 05067419922 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALDiscontinued—
    EQ 200MG BASETABLETORALDiscontinued—
  • NDA 05068819922 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
    EQ 50MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
  • NDA 05068719922 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALDiscontinued—
    EQ 200MG BASETABLETORALDiscontinued—

Generic (ANDA) products (8)

Abbreviated applications
  • CEFPODOXIME PROXETIL
    ANDA 21056820222 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALRxAB
    EQ 200MG BASETABLETORALRxAB
  • CEFPODOXIME PROXETIL
    ANDA 09003120092 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 50MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
    EQ 100MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
  • CEFPODOXIME PROXETIL
    ANDA 06546220082 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALRxAB
    EQ 200MG BASETABLETORALRxAB
  • CEFPODOXIME PROXETIL
    ANDA 06538820072 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALRxAB
    EQ 200MG BASETABLETORALRxAB
  • CEFPODOXIME PROXETIL
    ANDA 06537020072 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALRxAB
    EQ 200MG BASETABLETORALRxAB
  • CEFPODOXIME PROXETIL
    ANDA 06540920072 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 50MG BASE/5MLFOR SUSPENSIONORALRx—
    EQ 100MG BASE/5MLFOR SUSPENSIONORALRx—
  • CEFPODOXIME PROXETIL
    ANDA 06508320032 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALDiscontinued—
    EQ 200MG BASETABLETORALDiscontinued—
  • CEFPODOXIME PROXETIL
    ANDA 06508220022 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 50MG BASE/5MLFOR SUSPENSIONORALDiscontinued—
    EQ 100MG BASE/5MLFOR SUSPENSIONORALDiscontinued—

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
34 yr 8 mo ago
Most recent approval
4 yr 6 mo ago

Approvals span 1992–2022 across 12 FDA applications.

Brand (NDA) 433%
Generic (ANDA) 867%

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.

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