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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
McKesson
Farmers Insurance
AstraZeneca
Baxter
US Army
Johnson and Johnson
Boehringer Ingelheim
Federal Trade Commission
Fuji

Generated: February 22, 2018

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 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 021835
Tradename:CLOBEX
Applicant:Galderma Labs Lp
Ingredient:clobetasol propionate
Patents:2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 N 0299-3849-01
CLOBEX clobetasol propionate SPRAY;TOPICAL 021835 NDA Galderma Laboratories, L.P. 0299-3849 N 0299-3849-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrength0.05%
Approval Date:Oct 27, 2005TE:ATRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 12, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 24, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Teva
Harvard Business School
McKesson
Fish and Richardson
Healthtrust
Farmers Insurance
Chubb
QuintilesIMS

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