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FDA Orange Book · active-ingredient family

Flurandrenolide

Flurandrenolide: 3 brands, 5 generics; first approved Apr 29, 1982; 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
11

Brand (NDA) products

Originator applications
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  • NDA 012806-4 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%OINTMENTTOPICALDiscontinued-
    0.05%CREAMTOPICALDiscontinued-
    0.025%CREAMTOPICALDiscontinued-
    0.025%OINTMENTTOPICALDiscontinued-
  • NDA 013790-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%LOTIONTOPICALDiscontinued-
  • CORDRANRLDRS
    NDA 016455-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.004MG/SQ CMTAPETOPICALRx-

Generic (ANDA) products (5)

Abbreviated applications
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  • FLURANDRENOLIDERS
    ANDA 2078512016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%OINTMENTTOPICALRx-
  • FLURANDRENOLIDE
    ANDA 2053432016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%LOTIONTOPICALDiscontinued-
  • FLURANDRENOLIDERS
    ANDA 2071332016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%LOTIONTOPICALRx-
  • FLURANDRENOLIDE
    ANDA 2053422016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%CREAMTOPICALDiscontinued-
  • FLURANDRENOLIDE
    ANDA 0872031982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.05%LOTIONTOPICALDiscontinued-

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 2 mo ago
Most recent approval
9 yr 11 mo ago

Approvals span 1982–2016 across 8 FDA applications.

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

Flurandrenolide: 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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