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Generated: December 12, 2018

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Details for New Drug Application (NDA): 076793

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NDA 076793 describes FLUTICASONE PROPIONATE, which is a drug marketed by Anda Repository, Fougera Pharms, G And W Labs, Nesher Pharms, Perrigo New York, Glenmark Generics, Perrigo Israel, Taro Pharm Inds, Apotex Inc, Hi Tech Pharma, West-ward Pharms Int, and Wockhardt Bio Ag, and is included in seventeen NDAs. It is available from seventy-six suppliers. Additional details are available on the FLUTICASONE PROPIONATE profile page.

The generic ingredient in FLUTICASONE PROPIONATE 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 076793
Applicant:Perrigo New York
Ingredient:fluticasone propionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 076793
Suppliers and Packaging for NDA: 076793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTICASONE PROPIONATE fluticasone propionate CREAM;TOPICAL 076793 ANDA Perrigo New York Inc 45802-222 45802-222-11 1 TUBE in 1 CARTON (45802-222-11) > 30 g in 1 TUBE
FLUTICASONE PROPIONATE fluticasone propionate CREAM;TOPICAL 076793 ANDA Perrigo New York Inc 45802-222 45802-222-35 1 TUBE in 1 CARTON (45802-222-35) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:May 14, 2004TE:ABRLD:No

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