FDA.reportPublic FDA data

Application 215563

Type
ANDA
Sponsor
NOVITIUM PHARMA

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
51407-645Bisoprolol FumarateBisoprolol FumarateGolden State Medical Supply, Inc.ANDACurrent
51407-646Bisoprolol FumarateBisoprolol FumarateGolden State Medical Supply, Inc.ANDACurrent
70954-455Bisoprolol FumarateBisoprolol FumarateNovitium Pharma LLCANDACurrent
70954-456Bisoprolol FumarateBisoprolol FumarateNovitium Pharma LLCANDACurrent
71335-2178Bisoprolol FumarateBisoprolol FumarateBryant Ranch PrepackANDACurrent