FDA.reportPublic FDA data

Application 017919

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ORTHO-NOVUM 1/35-28ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG;1MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-176Ortho Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-176Ortho Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-176Ortho Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-176Ortho Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49472SUPPL2017-08-21
49320SUPPL2017-08-10
11093SUPPL2015-11-04
746SUPPL2015-11-04
33369SUPPL2013-10-04
13952SUPPL2013-10-04
13951SUPPL2013-10-04
13949SUPPL2013-10-04
745SUPPL2013-10-04
11092SUPPL2012-07-13
13950SUPPL2012-06-20