FDA.reportPublic FDA data

Application 075840

Type
ANDA
Sponsor
DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRYSELLEETHINYL ESTRADIOL; NORGESTRELTABLET;ORAL-210.03MG;0.3MGNoNo
002CRYSELLEETHINYL ESTRADIOL; NORGESTRELTABLET;ORAL-280.03MG;0.3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9049CryselleNorgestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-2183CryselleNorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2183CryselleNorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
53002-1188CryselleNorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
70518-1214CryselleNorgestrel and Ethinyl EstradiolREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8804ORIG2003-04-15