FDA.reportPublic FDA data

Application 203038

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.0025MG;0.5MGNoNo
002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.005MG;1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-656Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-656Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-657Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-657Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent