FDA.reportPublic FDA data

Application 211049

Type
ANDA
Sponsor
SUNSHINE LAKE

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
0527-2425OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2425OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2425OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2425OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2425OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2426OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2426OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2426OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2426OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2426OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2427OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2427OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2427OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2427OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
0527-2427OLMESARTAN MEDOXOMILOlmesartan medoxomilLannett Company, Inc.ANDACurrent
48792-7877OLMESARTAN MEDOXOMILOlmesartan medoxomilSunshine Lake Pharma Co., Ltd.ANDACurrent
48792-7878OLMESARTAN MEDOXOMILOlmesartan medoxomilSunshine Lake Pharma Co., Ltd.ANDACurrent
48792-7879OLMESARTAN MEDOXOMILOlmesartan medoxomilSunshine Lake Pharma Co., Ltd.ANDACurrent