FDA.reportPublic FDA data

Application 202743

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESPRAY, METERED;NASALEQ 0.1876MG BASE/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-026azelastine hcl nasalAzelastine HClPadagis Israel Pharmaceuticals LtdANDACurrent
45802-026azelastine hcl nasalAzelastine HClPerrigo New York IncANDACurrent
45802-026azelastine hcl nasalAzelastine HClPerrigo New York IncANDACurrent
45802-026azelastine hcl nasalAzelastine HClPerrigo New York IncANDACurrent
45802-026azelastine hcl nasalAzelastine HClPerrigo New York IncANDACurrent
63629-2519azelastine hcl nasalAzelastine HClBryant Ranch PrepackANDACurrent
63629-2519azelastine hcl nasalAzelastine HClBryant Ranch PrepackANDACurrent
63629-2519azelastine hcl nasalAzelastine HClBryant Ranch PrepackANDACurrent