FDA.reportPublic FDA data

Application 075474

Type
ANDA
Sponsor
FRONTIDA BIOPHARM

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
52817-270BisoprololBisoprolol fumarateTruPharma, LLCANDACurrent
52817-270BisoprololBisoprolol fumarateTruPharma, LLCANDACurrent
52817-270BisoprololBisoprolol fumarateTruPharma, LLCANDACurrent
52817-271BisoprololBisoprolol fumarateTruPharma, LLCANDACurrent
52817-271BisoprololBisoprolol fumarateTruPharma, LLCANDACurrent
52817-271BisoprololBisoprolol fumarateTruPharma, LLCANDACurrent
63629-6907BisoprololBisoprolol fumarateBryant Ranch PrepackANDACurrent
63629-6907BisoprololBisoprolol fumarateBryant Ranch PrepackANDACurrent
63629-6907BisoprololBisoprolol fumarateBryant Ranch PrepackANDACurrent
63629-6907BisoprololBisoprolol fumarateBryant Ranch PrepackANDACurrent
68071-5097BisoprololBisoprolol fumarateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5097BisoprololBisoprolol fumarateNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1678BisoprololBisoprolol fumarateBryant Ranch PrepackANDACurrent
71335-1678BisoprololBisoprolol fumarateBryant Ranch PrepackANDACurrent