FDA.reportPublic FDA data

Application 206220

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEPOTASTINE BESILATEBEPOTASTINE BESILATESOLUTION/DROPS;OPHTHALMIC1.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7055Bepotastine BesilateBepotastine BesilateMylan Pharmaceuticals Inc.ANDACurrent
0378-7055Bepotastine BesilateBepotastine BesilateMylan Pharmaceuticals Inc.ANDACurrent