FDA.reportPublic FDA data

Application 075768

Type
ANDA
Sponsor
MYLAN

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
0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
43063-134Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
70518-3207Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3333Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31013ORIG2000-09-25