Application 205876

Type
ANDA
Sponsor
APOTEX

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
60505-4183Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolApotex Corp.ANDACurrent
60505-4183Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolApotex Corp.ANDACurrent