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Generated: November 19, 2018

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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-eight drug master file entries for this compound. Eighty-four 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:1
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

Profile 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:➤ Try a Free TrialPatent 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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