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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 are seven patents 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 thirteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 021835

Galderma Labs Lp
clobetasol propionate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021835

Suppliers and Packaging for NDA: 021835

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrength0.05%
Approval Date:Oct 27, 2005TE:ATRLD:Yes
Patent:5,972,920Patent Expiration:Feb 12, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:5,990,100Patent Expiration:Mar 24, 2018Product Flag?YSubstance Flag?Delist Request?

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