FDA.reportPublic FDA data

Application 203435

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75834-129Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolNivagen Pharmaceuticals, Inc.ANDACurrent
75834-130Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl EstradiolNivagen Pharmaceuticals, Inc.ANDACurrent