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FDA Orange Book · active-ingredient family

Halothane

Halothane: 1 brand, 3 generics; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 3 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4

Brand (NDA) products

Originator applications
  • NDA 011338—
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    99.99%LIQUIDINHALATIONDiscontinued—

Generic (ANDA) products (3)

Abbreviated applications
  • HALOTHANE
    ANDA 084977—
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    99.99%LIQUIDINHALATIONDiscontinued—
  • HALOTHANE
    ANDA 080810—
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    99.99%LIQUIDINHALATIONDiscontinued—
  • HALOTHANE
    ANDA 083254—
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    99.99%LIQUIDINHALATIONDiscontinued—

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.

Halothane: 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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