FDA.reportPublic FDA data

Application 090794

Type
ANDA
Sponsor
XIROMED

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2029PrevifemNorgestimate and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0254-2029PrevifemNorgestimate and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0781-4058EstaryllaNorgestimate and ethinyl estradiolSandoz IncANDACurrent
42291-553Norgestimate and Ethinyl EstradiolNorgestimate and ethinyl estradiolAvKAREANDACurrent
42291-553Norgestimate and Ethinyl EstradiolNorgestimate and ethinyl estradiolAvKAREANDACurrent
53002-2191PrevifemNorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
63629-2349EstaryllaNorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2349EstaryllaNorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2349EstaryllaNorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
70518-2010PrevifemNorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2010PrevifemNorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2010PrevifemNorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70700-119EstaryllaNorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-119EstaryllaNorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-119EstaryllaNorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent