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Last Updated: April 19, 2024

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 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 021644

Tradename:	CLOBEX
Applicant:	Galderma Labs
Ingredient:	clobetasol propionate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021644

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021644

Anti-Inflammatory Agents
Glucocorticoids

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	0.05%
Approval Date:	Feb 5, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021644

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

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