FDA.reportPublic FDA data

Application 090114

Type
ANDA
Sponsor
XIROMED

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5658SyedaDrospirenone and Ethinyl EstradiolSandoz IncANDACurrent
63629-2335SyedaDrospirenone and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-2335SyedaDrospirenone and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-2335SyedaDrospirenone and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
70700-115SyedaDrospirenone and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-115SyedaDrospirenone and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-115SyedaDrospirenone and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-115SyedaDrospirenone and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-115SyedaDrospirenone and Ethinyl EstradiolXiromed, LLC.ANDACurrent