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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021835

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NDA 021835 describes CLOBEX, which is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs. It is available from five suppliers. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the CLOBEX profile page.

The generic ingredient in CLOBEX 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 021835
Applicant:Galderma Labs Lp
Ingredient:clobetasol propionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 021835
Medical Subject Heading (MeSH) Categories for 021835
Suppliers and Packaging for NDA: 021835
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBEX clobetasol propionate SPRAY;TOPICAL 021835 NDA Galderma Laboratories, L.P. 0299-3849 0299-3849-01 1 BOTTLE in 1 CARTON (0299-3849-01) > 10 mL in 1 BOTTLE
CLOBEX clobetasol propionate SPRAY;TOPICAL 021835 NDA Galderma Laboratories, L.P. 0299-3849 0299-3849-02 1 BOTTLE in 1 CARTON (0299-3849-02) > 59 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021835
Tradename Dosage Ingredient NDA Submissiondate
CLOBEX SPRAY;TOPICAL clobetasol propionate 021835 2008-09-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrength0.05%
Approval Date:Oct 27, 2005TE:ATRLD:Yes

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