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Serving 500+ biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Federal Trade Commission

Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077538

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NDA 077538 describes FLUTICASONE PROPIONATE, which is a drug marketed by Fougera Pharms, West-ward Pharms Int, Tolmar, Apotex Inc, Taro Pharm Inds, Perrigo Israel, G And W Labs, Glenmark Generics, Nesher Pharms, Perrigo New York, Hi Tech Pharma, and Wockhardt, and is included in seventeen NDAs. It is available from sixty-eight suppliers. Additional details are available on the FLUTICASONE PROPIONATE profile page.

The generic ingredient in FLUTICASONE PROPIONATE is fluticasone propionate. There are twenty-four drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 077538

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077538

Suppliers and Packaging for NDA: 077538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluticasone propionate
SPRAY, METERED;NASAL 077538 ANDA Blenheim Pharmacal, Inc. 10544-653 10544-653-99 1 BOTTLE, SPRAY in 1 CARTON (10544-653-99) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY
fluticasone propionate
SPRAY, METERED;NASAL 077538 ANDA PureTek Corporation 59088-392 59088-392-00 * 1 BOTTLE, SPRAY in 1 CARTON (60505-0829-1) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY * 1 BOTTLE, WITH APPLICATOR in 1 CARTON (GS1:705928051775) > 177 mL in 1 BOTTLE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/SPRAY
Approval Date:Sep 12, 2007TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Express Scripts
Argus Health
Harvard Business School
Chinese Patent Office

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