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Last Updated: November 21, 2019

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 four suppliers. There are four 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-eight 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
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 0299-3847-00 1 BOTTLE in 1 BLISTER PACK (0299-3847-00) > 15 mL in 1 BOTTLE (0299-3847-05)
CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644 NDA Galderma Laboratories, L.P. 0299-3847 0299-3847-04 1 BOTTLE in 1 CARTON (0299-3847-04) > 118 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021644
Tradename Dosage Ingredient NDA Submissiondate
CLOBEX SHAMPOO;TOPICAL clobetasol propionate 021644 2008-01-09

Profile for product number 001

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

Expired US Patents for NDA 021644

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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