FDA.reportPublic FDA data

Application 205482

Type
ANDA
Sponsor
JUBILANT GENERICS

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
59746-463olmesartan medoxomilolmesartan medoxomilJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-463olmesartan medoxomilolmesartan medoxomilJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-465olmesartan medoxomilolmesartan medoxomilJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-465olmesartan medoxomilolmesartan medoxomilJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-466olmesartan medoxomilolmesartan medoxomilJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-466olmesartan medoxomilolmesartan medoxomilJubilant Cadista Pharmaceuticals Inc.ANDACurrent