FDA.reportPublic FDA data

Application 021241

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO TRI-CYCLEN LOETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-251ORTHO TRI CYCLEN Lonorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-251ORTHO TRI CYCLEN Lonorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-251ORTHO TRI CYCLEN Lonorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-251ORTHO TRI CYCLEN Lonorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
52544-087TriNessa Lonorgestimate and ethinyl estradiolActavis Pharma, Inc.NDACurrent
53002-1454TriNessa Lonorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49373SUPPL2017-08-15
49293SUPPL2017-08-09
14713SUPPL2015-08-04
27176SUPPL2015-08-03
36433SUPPL2012-07-13
27175SUPPL2012-06-20
42046SUPPL2006-07-11
42045ORIG2004-08-26
27174ORIG2002-08-22
14712ORIG2002-08-22