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Last Updated: April 26, 2024

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 three suppliers. 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. 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:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021835

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021835

Anti-Inflammatory Agents
Glucocorticoids

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:	RX	Dosage:	SPRAY;TOPICAL			Strength	0.05%
Approval Date:	Oct 27, 2005	TE:	AT	RLD:	Yes

Expired US Patents for NDA 021835

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

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