FDA.reportPublic FDA data

Application 090538

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIELLYNETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG;0.4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-316BRIELLYNNorethindrone and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-316BRIELLYNNorethindrone and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent