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FDA Orange Book · active-ingredient family

Mivacurium chloride

Mivacurium chloride: 1 brand, 2 generics; first approved Jan 22, 1992; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 2 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
8

Brand (NDA) products

Originator applications
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  • NDA 02009819925 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 2MG BASE/ML (EQ 2MG BASE/ML)SOLUTIONINTRAVENOUSDiscontinued-
    EQ 0.5MG BASE/MLINJECTABLEINJECTIONDiscontinued-
    EQ 50MG BASE/100MLINJECTABLEINJECTIONDiscontinued-
    EQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTIONINTRAVENOUSDiscontinued-
    EQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTIONINTRAVENOUSDiscontinued-

Generic (ANDA) products (2)

Abbreviated applications
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  • MIVACURIUM CHLORIDE
    ANDA 20970820212 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTIONINTRAVENOUSDiscontinued-
    EQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTIONINTRAVENOUSDiscontinued-
  • MIVACURIUM CHLORIDE
    ANDA 0785622009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 2MG BASE/MLINJECTABLEINJECTIONDiscontinued-

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
35 yr 3 mo ago
Most recent approval
5 yr 1 mo ago

Approvals span 1992–2021 across 3 FDA applications.

Brand (NDA) 133%
Generic (ANDA) 267%

Mivacurium chloride: 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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