FDA.reportPublic FDA data

Application 204213

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-827FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-827FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-827FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-827FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-827FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-828FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-828FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-828FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-828FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-828FyavolvNorethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent