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FDA Orange Book · active-ingredient family

Amcinonide

Amcinonide: 3 brands, 5 generics; first approved Jun 13, 1988; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 5 ANDA applications approved.

Brands (NDA)
3
Generics (ANDA)
5
Listed patents
0
Presentations
9

Brand (NDA) products

Originator applications
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  • NDA 0197291988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%LOTIONTOPICALDiscontinued-
  • NDA 018116-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.025%CREAMTOPICALDiscontinued-
    0.1%CREAMTOPICALDiscontinued-
  • NDA 018498-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%OINTMENTTOPICALDiscontinued-

Generic (ANDA) products (5)

Abbreviated applications
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  • AMCINONIDE
    ANDA 0760652003
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%CREAMTOPICALDiscontinued-
  • AMCINONIDE
    ANDA 0763672003
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%OINTMENTTOPICALDiscontinued-
  • AMCINONIDERS
    ANDA 0760962002
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%OINTMENTTOPICALRx-
  • AMCINONIDERS
    ANDA 0763292002
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%LOTIONTOPICALRx-
  • AMCINONIDERS
    ANDA 0762292002
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.1%CREAMTOPICALRx-

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
38 yr 11 mo ago
Most recent approval
23 yr 10 mo ago

Approvals span 1988–2003 across 8 FDA applications.

Brand (NDA) 338%
Generic (ANDA) 563%

Amcinonide: 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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