FDA.reportPublic FDA data

Application 076221

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.005MG;1MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3122Jintelinorethindrone acetate and ethinyl estradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3122Jintelinorethindrone acetate and ethinyl estradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3122Jintelinorethindrone acetate and ethinyl estradiolTeva Pharmaceuticals USA,ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31100ORIG2009-11-09