FDA.reportPublic FDA data

Application 077910

Type
ANDA
Sponsor
AUROBINDO 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
16714-529Bisoprolol FumarateBisoprolol FumarateNorthStar Rx LLCANDACurrent
16714-530Bisoprolol FumarateBisoprolol FumarateNorthStar Rx LLCANDACurrent
50268-127Bisoprolol FumarateBisoprolol FumarateAvPAKANDACurrent
57237-132Bisoprolol FumarateBisoprolol FumarateCitron Pharma LLCANDACurrent
57237-133Bisoprolol FumarateBisoprolol FumarateCitron Pharma LLCANDACurrent
65862-086Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-086Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-086Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-086Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-087Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-087Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-087Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent
65862-087Bisoprolol FumarateBisoprolol FumarateAurobindo Pharma LimitedANDACurrent