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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021152

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NDA 021152 describes CUTIVATE, which is a drug marketed by Fougera Pharms and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CUTIVATE profile page.

The generic ingredient in CUTIVATE is fluticasone propionate. There are twenty-four drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 021152

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

Pharmacology for NDA: 021152

Suppliers and Packaging for NDA: 021152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUTIVATE
fluticasone propionate
LOTION;TOPICAL 021152 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0434 0168-0434-04 1 BOTTLE in 1 CARTON (0168-0434-04) > 120 mL in 1 BOTTLE
CUTIVATE
fluticasone propionate
LOTION;TOPICAL 021152 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0434 0168-0434-60 1 BOTTLE in 1 CARTON (0168-0434-60) > 60 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Mar 31, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 16, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Oct 20, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN PATIENTS ONE YEAR OF AGE OR OLDER


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Medtronic
Chubb
US Army
Accenture
McKinsey
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Deloitte
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Novartis

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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