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FDA Orange Book · active-ingredient family

Hydroflumethiazide

Hydroflumethiazide: 1 brand, 4 generics; first approved Apr 06, 1983; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 4 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5

Brand (NDA) products

Originator applications
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  • NDA 011949-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-

Generic (ANDA) products (4)

Abbreviated applications
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  • HYDROFLUMETHIAZIDE
    ANDA 0888501985
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROFLUMETHIAZIDE
    ANDA 0885281984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROFLUMETHIAZIDE
    ANDA 0880311983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • ANDA 083383-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-

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
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First approval
44 yr 2 mo ago
Most recent approval
42 yr ago

Approvals span 1983–1985 across 5 FDA applications.

Brand (NDA) 120%
Generic (ANDA) 480%

Hydroflumethiazide: 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

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