NDC 10337-301

TEMOVATE E

Clobetasol Propionate

TEMOVATE E is a Topical Cream 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 ID10337-301_ee16de89-1d93-43cb-9c93-2eab26bf180e
NDC10337-301
Product TypeHuman Prescription Drug
Proprietary NameTEMOVATE E
Generic NameClobetasol Propionate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1999-05-26
Marketing CategoryANDA / ANDA
Application NumberANDA075430
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 10337-301-60

1 TUBE in 1 CARTON (10337-301-60) > 60 g in 1 TUBE
Marketing Start Date1999-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10337-301-60 [10337030160]

TEMOVATE E CREAM
Marketing CategoryANDA
Application NumberANDA075430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-05-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:5b408bbb-5b3c-4b96-85b7-1a08e4b0f049
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992281
  • 1992282
  • Pharmacological Class

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

    NDC Crossover Matching brand name "TEMOVATE E" or generic name "Clobetasol Propionate"

    NDCBrand NameGeneric Name
    10337-301TEMOVATE ETEMOVATE E
    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
    0462-0269TemovateClobetasol Propionate
    0462-0293Temovateclobetasol propionate

    Trademark Results [TEMOVATE E]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TEMOVATE E
    TEMOVATE E
    75109594 2049183 Dead/Cancelled
    Glaxo Group Limited
    1996-05-22

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