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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075633

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NDA 075633 describes CLOBETASOL PROPIONATE (EMOLLIENT), which is a drug marketed by Fougera Pharms, Novast Labs Ltd, Taro, and Teligent Pharma Inc, and is included in four NDAs. It is available from five suppliers. Additional details are available on the CLOBETASOL PROPIONATE (EMOLLIENT) profile page.

The generic ingredient in CLOBETASOL PROPIONATE (EMOLLIENT) is clobetasol propionate. There are thirteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075633
Tradename:CLOBETASOL PROPIONATE (EMOLLIENT)
Applicant:Taro
Ingredient:clobetasol propionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075633
Medical Subject Heading (MeSH) Categories for 075633
Suppliers and Packaging for NDA: 075633
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075633 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1297 N 51672-1297-1
CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075633 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1297 N 51672-1297-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:May 17, 2000TE:AB2RLD:No

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