FDA.reportPublic FDA data

Application 203163

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASHLYNAETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.03MG,0.01MG;0.15MG,N/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2097AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2097AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2097AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
68462-646AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-646AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-646AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-646AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-646AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-646AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent