FDA.reportPublic FDA data

Application 076064

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JUNEL FE 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-280.03MG;1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9028JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9028JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9028JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9028JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9028JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9028JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
42254-242Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarateRebel Distributors CorpANDACurrent
51285-128LoestrinNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Women's Health, Inc.ANDACurrent
51285-128LoestrinNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Women's Health, Inc.ANDACurrent
51285-128LoestrinNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Women's Health, Inc.ANDACurrent
51285-128LoestrinNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Women's Health, Inc.ANDACurrent
51285-128LoestrinNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Women's Health, Inc.ANDACurrent
51285-129LoestrinNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateTeva Women's Health, Inc.ANDACurrent
63187-890Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarateProficient Rx LPANDACurrent
63187-890Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarateProficient Rx LPANDACurrent
63187-890Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarateProficient Rx LPANDACurrent
63187-890Junel Fe 1.5/30norethindrone acetate and ethinyl estradiol, and ferrous fumarateProficient Rx LPANDACurrent
68788-8113JunelNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumaratePreferred Pharmaceuticals Inc.ANDACurrent