FDA.reportPublic FDA data

Application 075796

Type
ANDA
Sponsor
DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVIANE-28ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoNo
002AVIANE-21ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-210.02MG;0.1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9045AvianeLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9045AvianeLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9045AvianeLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9045AvianeLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9045AvianeLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9045AvianeLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-995Avianelevonorgestrel and ethinyl estradiolRebel Distributors CorpANDACurrent
63187-889AvianeLevonorgestrel and Ethinyl EstradiolProficient Rx LPANDACurrent
63187-889AvianeLevonorgestrel and Ethinyl EstradiolProficient Rx LPANDACurrent
63187-889AvianeLevonorgestrel and Ethinyl EstradiolProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39491ORIG2004-05-27
22502ORIG2004-05-27
8793ORIG2004-05-27