FDA.reportPublic FDA data

Application 204848

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL-283MG;0.03MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2494drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-2494drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-2494drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolA-S Medication SolutionsANDACurrent
68462-733drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-733drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-733drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent