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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077168

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NDA 077168 describes FLUTICASONE PROPIONATE, which is a drug marketed by Fougera Pharms, G And W Labs, Nesher Pharms, Perrigo New York, Tolmar, Glenmark Generics, Perrigo Israel, Taro Pharm Inds, Apotex Inc, Hi Tech Pharma, West-ward Pharms Int, and Wockhardt, and is included in seventeen NDAs. It is available from seventy-three 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-one suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for 077168

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077168

Suppliers and Packaging for NDA: 077168

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTICASONE PROPIONATE fluticasone propionate OINTMENT;TOPICAL 077168 ANDA G&W Laboratories, Inc. 0713-0632 0713-0632-31 1 TUBE in 1 CARTON (0713-0632-31) > 30 g in 1 TUBE
FLUTICASONE PROPIONATE fluticasone propionate OINTMENT;TOPICAL 077168 ANDA G&W Laboratories, Inc. 0713-0632 0713-0632-15 1 TUBE in 1 CARTON (0713-0632-15) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.005%
Approval Date:Mar 3, 2006TE:ABRLD:No


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Fish and Richardson
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Moodys
Healthtrust
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Daiichi Sankyo
US Army

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