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Last Updated: July 3, 2020

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 two suppliers. Additional details are available on the CUTIVATE profile page.

The generic ingredient in CUTIVATE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 021152
Tradename:CUTIVATE
Applicant:Fougera Pharms
Ingredient:fluticasone propionate
Patents:0
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 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 Fougera Pharmaceuticals Inc. 0168-0434 0168-0434-60 1 BOTTLE in 1 CARTON (0168-0434-60) > 60 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021152
Tradename Dosage Ingredient NDA Submissiondate
CUTIVATE LOTION;TOPICAL fluticasone propionate 021152 2008-07-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Mar 31, 2005TE:ABRLD:Yes

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