Details for New Drug Application (NDA): 021535

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NDA 021535 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. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 021535

Tradename:	CLOBEX
Applicant:	Galderma Labs Lp
Ingredient:	clobetasol propionate
Patents:	0

Pharmacology for NDA: 021535

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021535

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 021535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535	NDA	Galderma Laboratories, L.P.	0299-3848	0299-3848-02	1 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE
CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535	NDA	Galderma Laboratories, L.P.	0299-3848	0299-3848-04	1 BOTTLE in 1 CARTON (0299-3848-04) / 118 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	0.05%
Approval Date:	Jul 24, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021535

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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