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FDA Orange Book ยท active-ingredient family

Liothyronine sodium

Liothyronine sodium: 2 brands, 10 generics; first approved Jan 25, 1982; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 10 ANDA applications approved.

Brands (NDA)
2
Generics (ANDA)
10
Listed patents
0
Presentations
28

Brand (NDA) products

Originator applications
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  • NDA 0201051991
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.01MG BASE/MLINJECTABLEINJECTIONDiscontinued-
  • NDA 010379-3 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB

Generic (ANDA) products (10)

Abbreviated applications
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  • LIOTHYRONINE SODIUM
    ANDA 21807020243 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB
  • LIOTHYRONINE SODIUM
    ANDA 21480320213 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB
  • LIOTHYRONINE SODIUM
    ANDA 21151020183 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB
  • LIOTHYRONINE SODIUM
    ANDA 09138220163 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB
  • LIOTHYRONINE SODIUM
    ANDA 20029520123 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB
  • LIOTHYRONINE SODIUM
    ANDA 09032620093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALDiscontinued-
    EQ 0.025MG BASETABLETORALDiscontinued-
    EQ 0.05MG BASETABLETORALDiscontinued-
  • LIOTHYRONINE SODIUM
    ANDA 09009720093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.005MG BASETABLETORALRxAB
    EQ 0.025MG BASETABLETORALRxAB
    EQ 0.05MG BASETABLETORALRxAB
  • LIOTHYRONINE SODIUMRS
    ANDA 0769232005
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.01MG BASE/MLINJECTABLEINJECTIONRx-
  • LIOTHYRONINE SODIUM
    ANDA 0857531982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.05MG BASETABLETORALDiscontinued-
  • LIOTHYRONINE SODIUM
    ANDA 0857551982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.025MG BASETABLETORALDiscontinued-

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
45 yr 5 mo ago
Most recent approval
2 yr 9 mo ago

Approvals span 1982โ€“2024 across 12 FDA applications.

Brand (NDA) 217%
Generic (ANDA) 1083%

Liothyronine 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.

Related FDA reference tools

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