FDA.reportPublic FDA data

Application 078738

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-938Azelastine HydrochlorideAzelastine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
68071-4359Azelastine HydrochlorideAzelastine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent