FDA.reportPublic FDA data

Application 202507

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELIFEMMEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70700-104LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl Estradiol TabletsXiromed, LLC.ANDACurrent
70700-104LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl Estradiol TabletsXiromed, LLC.ANDACurrent