FDA.reportPublic FDA data

Application 079106

Type
ANDA
Sponsor
UNICHEM

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
10544-173bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
10544-174bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
10544-563bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
29300-187bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-187bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-187bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-187bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-188bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-188bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-188bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-188bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-189bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-189bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-189bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-189bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
33261-918bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0796bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0796bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0796bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0796bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0799bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0799bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0799bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0799bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideA-S Medication SolutionsANDACurrent
63629-7150bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7150bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
67296-0947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-0947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-0947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-1268bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-1268bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-1268bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
68071-2131bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6880bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
70518-1947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70934-705bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0240bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0240bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0240bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0240bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0595bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0595bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0595bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0595bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0595bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1161bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1161bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1161bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1161bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideBryant Ranch PrepackANDACurrent