FDA.reportPublic FDA data

Application 202789

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISIBLOOMDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG;0.03MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2033EMOQUETTEdesogestrel and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0781-4066Isibloomdesogestrel and ethinyl estradiolSandoz IncANDACurrent
63629-2333Isibloomdesogestrel and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2333Isibloomdesogestrel and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2333Isibloomdesogestrel and ethinyl estradiolBryant Ranch PrepackANDACurrent
70518-2137EMOQUETTEdesogestrel and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2137EMOQUETTEdesogestrel and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2137EMOQUETTEdesogestrel and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2137EMOQUETTEdesogestrel and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-3029Isibloomdesogestrel and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70700-113Isibloomdesogestrel and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-113Isibloomdesogestrel and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-113Isibloomdesogestrel and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-113Isibloomdesogestrel and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-113Isibloomdesogestrel and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-113Isibloomdesogestrel and ethinyl estradiolXiromed, LLC.ANDACurrent