FDA.reportPublic FDA data

Application 079221

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORYNADROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL3MG;0.02MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5656Lorynadrospirenone and ethinyl estradiolSandoz IncANDACurrent
63629-2336LORYNADrospirenone and Ethinyl Estradiol TabletsBryant Ranch PrepackANDACurrent
63629-2336LORYNADrospirenone and Ethinyl Estradiol TabletsBryant Ranch PrepackANDACurrent
63629-2336LORYNADrospirenone and Ethinyl Estradiol TabletsBryant Ranch PrepackANDACurrent
70700-114LORYNADrospirenone and Ethinyl Estradiol TabletsXiromed, LLC.ANDACurrent
70700-114LORYNADrospirenone and Ethinyl Estradiol TabletsXiromed, LLC.ANDACurrent
70700-114LORYNADrospirenone and Ethinyl Estradiol TabletsXiromed, LLC.ANDACurrent
70700-114LORYNADrospirenone and Ethinyl Estradiol TabletsXiromed, LLC.ANDACurrent