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Generated: September 25, 2017

DrugPatentWatch Database Preview

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 five suppliers. There are seven 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 thirteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 021535

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021535

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Jul 24, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 22, 2017Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021535

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
CLOBEX
clobetasol propionate
LOTION;TOPICAL021535-001Jul 24, 2003► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKesson
Merck
McKinsey
Novartis
Teva
AstraZeneca
Julphar
Express Scripts
Daiichi Sankyo
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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