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Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
US Army
Queensland Health

Generated: December 10, 2017

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-five drug master file entries for this compound. Eighty-one suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for 019957

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 10337-333-30 30 g in 1 TUBE (10337-333-30)
CUTIVATE fluticasone propionate OINTMENT;TOPICAL 019957 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-333 10337-333-60 60 g in 1 TUBE (10337-333-60)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019957

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera PharmsCUTIVATEfluticasone propionateOINTMENT;TOPICAL019957-001Dec 14, 1990► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Express Scripts
Farmers Insurance
Daiichi Sankyo
Johnson and Johnson

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