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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-two drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 019957

Tradename:
CUTIVATE
Applicant:
Fougera Pharms
Ingredient:
fluticasone propionate
Patents:0
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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
CUTIVATE
fluticasone propionate
OINTMENT;TOPICAL019957-001Dec 14, 19904,335,121*PED► subscribe
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