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Generated: January 23, 2019

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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 four suppliers. There are six 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 fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 021535
Tradename:CLOBEX
Applicant:Galderma Labs Lp
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021535
Medical Subject Heading (MeSH) Categories for 021535
Suppliers and Packaging for NDA: 021535
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBEX 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
CLOBEX 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Jul 24, 2003TE:ABRLD:Yes

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