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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019957

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NDA 019957 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-six drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 019957
Applicant:Fougera Pharms
Ingredient:fluticasone propionate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019957
Suppliers and Packaging for NDA: 019957
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUTIVATE fluticasone propionate OINTMENT;TOPICAL 019957 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-333 N 10337-333-30
CUTIVATE fluticasone propionate OINTMENT;TOPICAL 019957 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-333 N 10337-333-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.005%
Approval Date:Dec 14, 1990TE:ABRLD:Yes

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