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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Federal Trade Commission
US Department of Justice

Generated: November 24, 2017

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Details for New Drug Application (NDA): 076504

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NDA 076504 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 seventy-one suppliers. Additional details are available on the FLUTICASONE PROPIONATE profile page.

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

Summary for 076504

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

Pharmacology for NDA: 076504

Suppliers and Packaging for NDA: 076504

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluticasone propionate
SPRAY, METERED;NASAL 076504 ANDA West-Ward Pharmaceuticals Corp. 0054-3270 0054-3270-99 1 BOTTLE, GLASS in 1 CARTON (0054-3270-99) > 120 SPRAY, METERED in 1 BOTTLE, GLASS
fluticasone propionate
SPRAY, METERED;NASAL 076504 ANDA Physicians Total Care, Inc. 54868-5545 54868-5545-0 1 BOTTLE, GLASS in 1 CARTON (54868-5545-0) > 120 SPRAY, METERED in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/SPRAY
Approval Date:Feb 22, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Harvard Business School
Farmers Insurance
Fish and Richardson
Daiichi Sankyo

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