FDA.reportPublic FDA data

Application 075644

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BISOPROLOL FUMARATEBISOPROLOL FUMARATETABLET;ORAL5MGNoNo
002BISOPROLOL FUMARATEBISOPROLOL FUMARATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5270Bisoprolol FumarateBisoprolol FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5271Bisoprolol FumarateBisoprolol FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent