FDA.reportPublic FDA data

Application 079064

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INTROVALEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.03MG;0.15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5584IntrovaleLevonorgestrel and Ethinyl EstradiolSandoz IncANDACurrent
70700-117IntrovaleLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-117IntrovaleLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-117IntrovaleLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-117IntrovaleLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-117IntrovaleLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent
70700-117IntrovaleLevonorgestrel and Ethinyl EstradiolXiromed, LLC.ANDACurrent