FDA.reportPublic FDA data

Application 207514

Type
ANDA
Sponsor
AMNEAL PHARMS

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
60219-1031Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-1031Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-1031Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-1031Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals LLCANDACurrent
69238-1031Melodetta 24 FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1031Melodetta 24 FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1031Melodetta 24 FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1031Melodetta 24 FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAmneal Pharmaceuticals LLCANDACurrent