FDA.reportPublic FDA data

Application 210612

Type
ANDA
Sponsor
NOVAST LABS

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
50742-657Estradiol and Norethindrone AcetateEstradiol and Norethindrone AcetateIngenus Pharmaceuticals, LLCANDACurrent
50742-657Estradiol and Norethindrone AcetateEstradiol and Norethindrone AcetateIngenus Pharmaceuticals, LLCANDACurrent
50742-658Estradiol and Norethindrone AcetateEstradiol and Norethindrone AcetateIngenus Pharmaceuticals, LLCANDACurrent
50742-658Estradiol and Norethindrone AcetateEstradiol and Norethindrone AcetateIngenus Pharmaceuticals, LLCANDACurrent