FDA.reportPublic FDA data

Application 091232

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-LO-ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-4062Tri-Lo- Estaryllanorgestimate and ethinyl estradiolSandoz IncANDACurrent
42291-565Norgestimate and Ethinyl Estradiolnorgestimate and ethinyl estradiolAvKAREANDACurrent
42291-565Norgestimate and Ethinyl Estradiolnorgestimate and ethinyl estradiolAvKAREANDACurrent
63629-2351Tri-Lo- Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2351Tri-Lo- Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2351Tri-Lo- Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent