FDA.reportPublic FDA data

Application 212678

Type
ANDA
Sponsor
EDENBRIDGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL2.5MG;6.25MGNoNo
002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MGNoNo
003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;6.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42799-920Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-920Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-920Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-920Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-921Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-921Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-921Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-921Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-922Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-922Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-922Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-922Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEdenbridge Pharmaceuticals LLC.ANDACurrent
50090-5849Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5905Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideA-S Medication SolutionsANDACurrent
70518-3530Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-1769Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1769Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1931Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1931Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideBryant Ranch PrepackANDACurrent