FDA.reportPublic FDA data

Application 210032

Type
ANDA
Sponsor
HI TECH

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
50383-942Azelastine HydrochlorideAzelastine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-942Azelastine HydrochlorideAzelastine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-942Azelastine HydrochlorideAzelastine HydrochlorideAkornANDACurrent
50383-942Azelastine HydrochlorideAzelastine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent