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Generated: January 23, 2019

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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 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 021835
Tradename:CLOBEX
Applicant:Galderma Labs Lp
Ingredient:clobetasol propionate
Patents:2
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 0299-3849-01 1 BOTTLE in 1 CARTON (0299-3849-01) > 10 mL in 1 BOTTLE
CLOBEX clobetasol propionate SPRAY;TOPICAL 021835 NDA Galderma Laboratories, L.P. 0299-3849 0299-3849-02 1 BOTTLE in 1 CARTON (0299-3849-02) > 59 mL in 1 BOTTLE

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.

Expired US Patents for NDA 021835

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Covington
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McKinsey
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Johnson and Johnson

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