FDA.reportPublic FDA data

Application 205192

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL5MGNoNo
002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL20MGNoNo
003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-643olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-643olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-643olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-643olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-644olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-644olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-644olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-644olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-645olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-645olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-645olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-645olmesartan medoxomilolmesartan medoxomilZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1059olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1059olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1059olmesartan medoxomilolmesartan medoxomilZydus Lifesciences LimitedANDACurrent
70771-1059olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1060olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1060olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1060olmesartan medoxomilolmesartan medoxomilZydus Lifesciences LimitedANDACurrent
70771-1060olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1061olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1061olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
70771-1061olmesartan medoxomilolmesartan medoxomilZydus Lifesciences LimitedANDACurrent
70771-1061olmesartan medoxomilolmesartan medoxomilCadila Healthcare LimitedANDACurrent
71335-1019olmesartan medoxomilolmesartan medoxomilBryant Ranch PrepackANDACurrent