FDA.reportPublic FDA data

Application 207712

Type
ANDA
Sponsor
APOTEX

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
60505-0953Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionateApotex Corp.ANDACurrent
60505-0953Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionateApotex Corp.ANDACurrent
60505-0953Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionateApotex Corp.ANDACurrent
60505-0953Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionateApotex Corp.ANDACurrent
60505-0953Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionateApotex Corp.ANDACurrent