FDA.reportPublic FDA data

Application 075809

Type
ANDA
Sponsor
DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENPRESSE-21ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-210.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MGNoNo
002ENPRESSE-28ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9047EnpresseLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9047EnpresseLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9047EnpresseLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9047EnpresseLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9047EnpresseLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9047EnpresseLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-855Enpresselevonorgestrel and ethinyl estradiolRebel Distributors CorpANDACurrent