FDA.reportPublic FDA data

Application 205948

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYDEMYDROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUMTABLET;ORAL3MG,N/A;0.03MG,N/A;0.451MG,0.451MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-904TydemyDrospirenone, Ethinyl Estradiol and Levomefolate Calcium and Levomefolate CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-904TydemyDrospirenone, Ethinyl Estradiol and Levomefolate Calcium and Levomefolate CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-904TydemyDrospirenone, Ethinyl Estradiol and Levomefolate Calcium and Levomefolate CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-904TydemyDrospirenone, Ethinyl Estradiol and Levomefolate Calcium and Levomefolate CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-904TydemyDrospirenone, Ethinyl Estradiol and Levomefolate Calcium and Levomefolate CalciumLupin Pharmaceuticals, Inc.ANDACurrent