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FDA Orange Book · active-ingredient family

Indapamide

Indapamide: 1 brand, 9 generics; first approved Jul 06, 1983; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 9 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
20

Brand (NDA) products

Originator applications
  • NDA 01853819932 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MGTABLETORALDiscontinued—
    1.25MGTABLETORALDiscontinued—

Generic (ANDA) products (9)

Abbreviated applications
  • INDAPAMIDE
    ANDA 07520119982 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.25MGTABLETORALDiscontinued—
    2.5MGTABLETORALDiscontinued—
  • INDAPAMIDE
    ANDA 07510519982 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.25MGTABLETORALDiscontinued—
    2.5MGTABLETORALDiscontinued—
  • INDAPAMIDE
    ANDA 07449819982 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MGTABLETORALDiscontinued—
    1.25MGTABLETORALDiscontinued—
  • INDAPAMIDE
    ANDA 07466519972 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.25MGTABLETORALDiscontinued—
    2.5MGTABLETORALDiscontinued—
  • INDAPAMIDE
    ANDA 07446119972 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MGTABLETORALRxAB
    1.25MGTABLETORALRxAB
  • INDAPAMIDE
    ANDA 07458519962 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.25MGTABLETORALDiscontinued—
    2.5MGTABLETORALDiscontinued—
  • INDAPAMIDE
    ANDA 07472219962 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.25MGTABLETORALRxAB
    2.5MGTABLETORALRxAB
  • INDAPAMIDE
    ANDA 07459419962 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.25MGTABLETORALDiscontinued—
    2.5MGTABLETORALDiscontinued—
  • INDAPAMIDE
    ANDA 07429919962 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MGTABLETORALRxAB
    1.25MGTABLETORALRxAB

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
43 yr 11 mo ago
Most recent approval
28 yr 3 mo ago

Approvals span 1983–1998 across 10 FDA applications.

Brand (NDA) 110%
Generic (ANDA) 990%

Indapamide: 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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