FDA.reportPublic FDA data

Application 211335

Type
ANDA
Sponsor
SUNSHINE LAKE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
48792-7887TADALAFILTadalafilSunshine Lake Pharma Co., Ltd.ANDACurrent
48792-7888TADALAFILTadalafilSunshine Lake Pharma Co., Ltd.ANDACurrent
48792-7889TADALAFILTadalafilSunshine Lake Pharma Co., Ltd.ANDACurrent
48792-7890TADALAFILTadalafilSunshine Lake Pharma Co., Ltd.ANDACurrent
72303-0822TADALAFILTadalafilHEC Pharm USA Inc.ANDACurrent
72303-0823TADALAFILTadalafilHEC Pharm USA Inc.ANDACurrent
72303-0824TADALAFILTadalafilHEC Pharm USA Inc.ANDACurrent
72303-0825TADALAFILTadalafilHEC Pharm USA Inc.ANDACurrent