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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 208183


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NDA 208183 describes ULTRAVATE, which is a drug marketed by Sun Pharm Inds Inc and Lacer Pharma and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ULTRAVATE profile page.

The generic ingredient in ULTRAVATE is halobetasol propionate. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 208183
Tradename:ULTRAVATE
Applicant:Lacer Pharma
Ingredient:halobetasol propionate
Patents:1
Pharmacology for NDA: 208183
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 208183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAVATE halobetasol propionate LOTION;TOPICAL 208183 NDA Lacer Pharma, LLC 73159-008 73159-008-60 1 BOTTLE in 1 CARTON (73159-008-60) / 59 g in 1 BOTTLE
ULTRAVATE halobetasol propionate LOTION;TOPICAL 208183 NDA AUTHORIZED GENERIC Coral Way Pharma, LLC 85437-008 85437-008-60 1 BOTTLE in 1 CARTON (85437-008-60) / 59 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Nov 6, 2015TE:RLD:Yes
Patent:8,962,028Patent Expiration:Jun 19, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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