FDA.reportPublic FDA data

Application 075951

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATENORETHINDRONE ACETATETABLET;ORAL5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0211Norethindrone AcetateNorethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0211Norethindrone AcetateNorethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0211Norethindrone AcetateNorethindrone AcetateTeva Pharmaceuticals USA,ANDACurrent
0555-0211Norethindrone AcetateNorethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
51285-424AygestinNorethindrone AcetateTeva Women's Health, Inc.ANDACurrent
51285-424AygestinNorethindrone AcetateTeva Women's Health, Inc.ANDACurrent
51285-424AygestinNorethindrone AcetateTeva Women's Health, Inc.ANDACurrent
51285-424AygestinNorethindrone AcetateTeva Women's Health, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43039ORIG2003-12-24
18429ORIG2003-12-24
31050ORIG2001-05-25