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FDA Orange Book · active-ingredient family

Foscarnet sodium

Foscarnet sodium: 1 brand, 7 generics; first approved Sep 27, 1991; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 7 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
10

Brand (NDA) products

Originator applications
  • NDA 02006819912 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
    12GM/500ML (24MG/ML)SOLUTIONINTRAVENOUSDiscontinued—

Generic (ANDA) products (7)

Abbreviated applications
  • FOSCARNET SODIUM
    ANDA 2200682026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
  • FOSCARNET SODIUM
    ANDA 2166022024
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
  • FOSCARNET SODIUM
    ANDA 2139872023
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
  • FOSCARNET SODIUM
    ANDA 2138072023
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
  • FOSCARNET SODIUM
    ANDA 2130012021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
  • FOSCARNET SODIUM
    ANDA 2124832021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSRxAP
  • FOSCARNET SODIUM
    ANDA 07717420052 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    6GM/250ML (24MG/ML)SOLUTIONINTRAVENOUSDiscontinued—
    12GM/500ML (24MG/ML)SOLUTIONINTRAVENOUSDiscontinued—

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
35 yr 7 mo ago
Most recent approval
5 mo ago

Approvals span 1991–2026 across 8 FDA applications.

Brand (NDA) 113%
Generic (ANDA) 788%

Foscarnet sodium: 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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