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US Department of Justice

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021644

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NDA 021644 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 021644
Tradename:CLOBEX
Applicant:Galderma Labs
Ingredient:clobetasol propionate
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 021644
Medical Subject Heading (MeSH) Categories for 021644
Suppliers and Packaging for NDA: 021644
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644 NDA Galderma Laboratories, L.P. 0299-3847 N 0299-3847-00
CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644 NDA Galderma Laboratories, L.P. 0299-3847 N 0299-3847-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength0.05%
Approval Date:Feb 5, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 17, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 3, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF SCALP PSORIASIS
Patent:➤ Sign UpPatent Expiration:Jun 17, 2019Product Flag?YSubstance Flag?Delist Request?

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