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Generated: November 16, 2018

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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 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 076504
Tradename:FLUTICASONE PROPIONATE
Applicant:West-ward Pharms Int
Ingredient:fluticasone propionate
Patents:0
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 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 fluticasone propionate SPRAY, METERED;NASAL 076504 ANDA A-S Medication Solutions 50090-2879 50090-2879-0 1 BOTTLE, GLASS in 1 CARTON (50090-2879-0) > 120 SPRAY, METERED in 1 BOTTLE, GLASS

Profile 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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