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Generated: November 12, 2018

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Details for New Drug Application (NDA): 209411

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NDA 209411 describes CLOBETASOL PROPIONATE (EMOLLIENT), which is a drug marketed by Fougera Pharms, Novast Labs, 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 fourteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 209411
Tradename:CLOBETASOL PROPIONATE (EMOLLIENT)
Applicant:Teligent Pharma Inc
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209411
Medical Subject Heading (MeSH) Categories for 209411
Suppliers and Packaging for NDA: 209411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 209411 ANDA Teligent Pharma, Inc. 52565-094 52565-094-15 1 TUBE in 1 CARTON (52565-094-15) > 15 g in 1 TUBE
CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 209411 ANDA Teligent Pharma, Inc. 52565-094 52565-094-30 1 TUBE in 1 CARTON (52565-094-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Aug 21, 2017TE:AB2RLD:No

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