FDA.reportPublic FDA data

Application 018985

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO-NOVUM 7/7/7-21ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-210.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGNoNo
002ORTHO-NOVUM 7/7/7-28ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0159Ortho-Novumnorethindrone and ethinyl estradiolA-S Medication Solutions LLCNDACurrent
50458-178Ortho-Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-178Ortho-Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-178Ortho-Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-178Ortho-Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-178Ortho-Novumnorethindrone and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
52544-165Neconnorethindrone and ethinyl estradiolActavis Pharma, Inc.NDACurrent
68258-5005Necon 777norethindrone and ethinyl estradiolDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49473SUPPL2017-08-21
49321SUPPL2017-08-10
11402SUPPL2015-11-04
1180SUPPL2015-11-04
33679SUPPL2013-10-04
16158SUPPL2013-10-04
16157SUPPL2013-10-04
1179SUPPL2013-10-04
1178SUPPL2013-10-04
11401SUPPL2012-07-13
16156SUPPL2012-06-20