FDA.reportPublic FDA data

Application 203770

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JAIMIESSETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.03MG,0.01MG;0.15MG,N/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2345JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2345JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2345JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolBryant Ranch PrepackANDACurrent
70700-123JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-123JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-123JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-123JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-123JAIMIESSlevonorgestrel / ethinyl estradiol and ethinyl estradiolXiromed, LLC.ANDACurrent