FDA.reportPublic FDA data

Application 207261

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.5MG;0.1MGNoNo
002ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL1MG;0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7294ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-7294ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-7294ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-7295ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-7295ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-7295ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetateMylan Pharmaceuticals Inc.ANDACurrent