NDC 0462-0293

Temovate

Clobetasol Propionate

Temovate is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.. The primary component is Clobetasol Propionate.

Product ID0462-0293_7675b274-767c-48c5-97ef-a53cbd5be28a
NDC0462-0293
Product TypeHuman Prescription Drug
Proprietary NameTemovate
Generic NameClobetasol Propionate
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date1994-04-29
Marketing CategoryNDA / NDA
Application NumberNDA020337
Labeler NamePharmaDerm, A division of Fougera Pharmaceuticals Inc.
Substance NameCLOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0462-0293-60

1 TUBE in 1 CARTON (0462-0293-60) > 60 g in 1 TUBE
Marketing Start Date1994-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0462-0293-60 [00462029360]

Temovate GEL
Marketing CategoryNDA
Application NumberNDA020337
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1994-04-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:ecc6049d-2c2a-40e0-8780-158b166af406
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861434
  • 861440
    • UPC Code
  • 0304680322767

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Temovate" or generic name "Clobetasol Propionate"

    NDCBrand NameGeneric Name
    0462-0269TemovateClobetasol Propionate
    0462-0293Temovateclobetasol propionate
    10337-163TemovateTemovate
    10337-162TemovateTemovate
    0168-0162Clobetasol Propionateclobetasol propionate
    0168-0163Clobetasol Propionateclobetasol propionate
    0168-0269Clobetasol PropionateClobetasol Propionate
    0168-0293Clobetasol Propionateclobetasol propionate
    0378-8055Clobetasol PropionateClobetasol Propionate
    0378-8167clobetasol propionateclobetasol propionate
    0378-8190Clobetasol PropionateClobetasol Propionate
    0472-0400Clobetasol PropionateClobetasol Propionate
    0472-0402Clobetasol PropionateClobetasol Propionate
    0472-0403Clobetasol PropionateClobetasol Propionate
    0472-0404Clobetasol PropionateClobetasol Propionate
    0574-2063Clobetasol PropionateCLOBETASOL PROPIONATE
    0574-2103Clobetasol PropionateClobetasol Propionate
    0168-0301Clobetasol Propionate (emollient)clobetasol propionate
    0299-3847Clobexclobetasol propionate
    0299-3848ClobexClobetasol Propionate
    0299-3849CLOBEXclobetasol propionate
    0378-8182OLUXclobetasol propionate
    0378-8147OLUX-Eclobetasol propionate

    Trademark Results [Temovate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TEMOVATE
    TEMOVATE
    73585431 1428974 Live/Registered
    GLAXO GROUP LIMITED
    1986-03-03
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.