FDA.reportPublic FDA data

Application 209609

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET, CHEWABLE;ORAL0.02MG;1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70700-101Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate TabletsXiromed, LLCANDACurrent
70700-101Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate TabletsXiromed, LLCANDACurrent
70700-101Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate TabletsXiromed, LLCANDACurrent
70700-101Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate TabletsXiromed, LLCANDACurrent