FDA.reportPublic FDA data

Application 209620

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

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
62332-506Azelastine Hydrochloride Ophthalmic Solution 0.05%Azelastine Hydrochloride Ophthalmic Solution 0.05%Alembic Pharmaceuticals Inc.ANDACurrent
62332-506Azelastine Hydrochloride Ophthalmic Solution 0.05%Azelastine Hydrochloride Ophthalmic Solution 0.05%Alembic Pharmaceuticals Inc.ANDACurrent
62332-506Azelastine Hydrochloride Ophthalmic Solution 0.05%Azelastine Hydrochloride Ophthalmic Solution 0.05%Alembic Pharmaceuticals Inc.ANDACurrent