FDA.reportPublic FDA data

Application 211944

Type
ANDA
Sponsor
HETERO LABS 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
31722-934Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolCamber Pharmaceuticals, Inc.ANDACurrent
63629-1931Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-1931Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolBryant Ranch PrepackANDACurrent