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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 209483

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NDA 209483 describes IMPOYZ, which is a drug marketed by Encore Dermat and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the IMPOYZ profile page.

The generic ingredient in IMPOYZ is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 209483
Applicant:Encore Dermat
Ingredient:clobetasol propionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 209483
Medical Subject Heading (MeSH) Categories for 209483
Suppliers and Packaging for NDA: 209483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMPOYZ clobetasol propionate CREAM;TOPICAL 209483 NDA Encore Dermatology, Inc 69482-700 69482-700-66 1 TUBE in 1 CARTON (69482-700-66) > 100 g in 1 TUBE (69482-700-99)
Paragraph IV (Patent) Challenges for 209483
Tradename Dosage Ingredient NDA Submissiondate
IMPOYZ CREAM;TOPICAL clobetasol propionate 209483 2019-12-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Nov 28, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 28, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:PSORIASIS
Patent:  Start TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?

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