FDA.reportPublic FDA data

Application 208111

Type
ANDA
Sponsor
PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATESPRAY, METERED;NASALEQ 0.125MG BASE/SPRAY;0.05MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-066AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionatePadagis Israel Pharmaceuticals LtdANDACurrent
45802-066AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionatePadagis Israel Pharmaceuticals LtdANDACurrent
45802-066AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionatePerrigo New York IncANDACurrent
63629-8612AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionateBryant Ranch PrepackANDACurrent
63629-8612AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionateBryant Ranch PrepackANDACurrent
63629-8612AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionateBryant Ranch PrepackANDACurrent