FDA.reportPublic FDA data

Application 204296

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL3MG;0.02MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2594drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-2594drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolA-S Medication SolutionsANDACurrent
53002-1735drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1735drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-720drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-720drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-720drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-720drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-720drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-720drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
71205-144drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolProficient Rx LPANDACurrent
71205-144drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolProficient Rx LPANDACurrent
71205-144drospirenone and ethinyl estradioldrospirenone and ethinyl estradiolProficient Rx LPANDACurrent