FDA.reportPublic FDA data

Application 206631

Type
ANDA
Sponsor
LUPIN LTD

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
68180-724OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-724OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-724OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-725OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-725OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-725OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-726OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-726OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent
68180-726OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLupin Pharmaceuticals, Inc.ANDACurrent