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Details for New Drug Application (NDA): 021535

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NDA 021535 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 twelve drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 021535

Pharmacology for NDA: 021535

Suppliers and Packaging for NDA: 021535

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clobetasol propionate
LOTION;TOPICAL 021535 NDA Galderma Laboratories, L.P. 0299-3848 0299-3848-02 1 BOTTLE in 1 CARTON (0299-3848-02) > 59 mL in 1 BOTTLE
clobetasol propionate
LOTION;TOPICAL 021535 NDA Galderma Laboratories, L.P. 0299-3848 0299-3848-04 1 BOTTLE in 1 CARTON (0299-3848-04) > 118 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Jul 24, 2003TE:ABRLD:Yes
Patent:6,106,848Patent Expiration:Sep 22, 2017Product Flag?Substance Flag?Delist Request?

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