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FDA Orange Book · active-ingredient family

Methazolamide

Methazolamide: 1 brand, 8 generics; first approved Nov 25, 1991; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 8 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
18

Brand (NDA) products

Originator applications
  • NDA 01172119912 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued—
    25MGTABLETORALDiscontinued—

Generic (ANDA) products (8)

Abbreviated applications
  • METHAZOLAMIDE
    ANDA 21740820262 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • METHAZOLAMIDE
    ANDA 21561520222 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • METHAZOLAMIDE
    ANDA 20743820182 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • METHAZOLAMIDE
    ANDA 04001119972 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued—
    50MGTABLETORALDiscontinued—
  • METHAZOLAMIDE
    ANDA 04010219962 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued—
    50MGTABLETORALDiscontinued—
  • METHAZOLAMIDE
    ANDA 04006219942 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • METHAZOLAMIDE
    ANDA 04000119932 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • METHAZOLAMIDE
    ANDA 04003619932 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB

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 5 mo ago
Most recent approval
8 mo ago

Approvals span 1991–2026 across 9 FDA applications.

Brand (NDA) 111%
Generic (ANDA) 889%

Methazolamide: 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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