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Colorcon
Daiichi Sankyo
Federal Trade Commission
Covington
Boehringer Ingelheim
Farmers Insurance
McKesson
QuintilesIMS
Cerilliant

Generated: May 23, 2018

DrugPatentWatch Database Preview

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 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 thirteen drug master file entries for this compound. Forty-three 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 N 0299-3848-02
CLOBEX clobetasol propionate LOTION;TOPICAL 021535 NDA Galderma Laboratories, L.P. 0299-3848 N 0299-3848-04

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Department of Justice
Chinese Patent Office
Medtronic
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Dow
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Mallinckrodt
Merck

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