FDA.reportPublic FDA data

Application 091346

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIORELEDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG,N/A;0.02MG,0.01MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1395VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-1395VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-1395VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
68462-318VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-318VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-318VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-318VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-318VIORELEDesogestrel and Ethinyl Estradiol and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent