FDA.reportPublic FDA data

Application 090793

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2030Tri-Previfemnorgestimate and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0254-2030Tri-Previfemnorgestimate and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0781-4060Tri-Estaryllanorgestimate and ethinyl estradiolSandoz IncANDACurrent
42291-590norgestimate and ethinyl estradiolnorgestimate and ethinyl estradiolAvKAREANDACurrent
42291-590norgestimate and ethinyl estradiolnorgestimate and ethinyl estradiolAvKAREANDACurrent
53002-2304Tri-Previfemnorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
63629-2350Tri-Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2350Tri-Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2350Tri-Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
70700-121Tri-Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-121Tri-Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-121Tri-Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-121Tri-Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent