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Generated: September 25, 2017

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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 seventy 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-seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 077538

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: 077538

Suppliers and Packaging for NDA: 077538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTICASONE PROPIONATE
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
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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Dow
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