FDA.reportPublic FDA data

Application 076381

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JUNEL 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-210.03MG;1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9027JunelNorethindrone Acetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9027JunelNorethindrone Acetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9027JunelNorethindrone Acetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9027JunelNorethindrone Acetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9027JunelNorethindrone Acetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9027JunelNorethindrone Acetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
51285-127LoestrinNorethindrone Acetate and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-127LoestrinNorethindrone Acetate and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-127LoestrinNorethindrone Acetate and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-127LoestrinNorethindrone Acetate and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-127LoestrinNorethindrone Acetate and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent