FDA.reportPublic FDA data

Application 202689

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOLNEADESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG,N/A;0.02MG,0.01MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2449VolneaDesogestrel and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-2449VolneaDesogestrel and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-2449VolneaDesogestrel and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
70700-122VolneaDesogestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-122VolneaDesogestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-122VolneaDesogestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-122VolneaDesogestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent