Application 091444

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESPRAY, METERED;NASALEQ 0.125MG BASE/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0293Azelastine HydrochlorideAzelastine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent