FDA.reportPublic FDA data

Application 075866

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PORTIA-21ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-210.03MG;0.15MGNoNo
002PORTIA-28ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG;0.15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9020PortiaLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent