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Last Updated: May 26, 2022

Details for New Drug Application (NDA): 209483


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NDA 209483 describes IMPOYZ, which is a drug marketed by Primus Pharms and is included in one NDA. It is available from two suppliers. 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-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 209483
Tradename:IMPOYZ
Applicant:Primus Pharms
Ingredient:clobetasol propionate
Patents:4
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 Primus Pharmaceuticals, Inc. 68040-713 68040-713-38 1 TUBE in 1 CARTON (68040-713-38) > 100 g in 1 TUBE
IMPOYZ clobetasol propionate CREAM;TOPICAL 209483 NDA Encore Dermatology, Inc 69482-700 69482-700-99 1 TUBE in 1 CARTON (69482-700-99) > 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Nov 28, 2017TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:PSORIASIS
Patent:See Plans and PricingPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE PLAQUE PSORIASIS
Patent:See Plans and PricingPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS

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