FDA.reportPublic FDA data

Application 215995

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

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
50090-6030Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideA-S Medication SolutionsANDACurrent
68462-878Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideGLENMARK PHARMACEUTICALS INC., USAANDACurrent
68462-878Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideGLENMARK PHARMACEUTICALS INC., USAANDACurrent
68462-879Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideGLENMARK PHARMACEUTICALS INC., USAANDACurrent
68462-879Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideGLENMARK PHARMACEUTICALS INC., USAANDACurrent
68462-880Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideGLENMARK PHARMACEUTICALS INC., USAANDACurrent
68462-880Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideGLENMARK PHARMACEUTICALS INC., USAANDACurrent