FDA.reportPublic FDA data

Application 090938

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.02MG;1MGNoNo
002FERROUS FUMARATEFERROUS FUMARATETABLET; ORAL75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5328Junel FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5328Junel FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5328Junel FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5328Junel FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5328Junel FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5328Junel FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent