FDA.reportPublic FDA data

Application 019697

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO TRI-CYCLENETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGYesYes
002ORTHO TRI-CYCLENETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-210.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-407TriNessaNorgestimate and Ethinyl EstradiolRebel Distributors CorpNDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74537SUPPL 2023-06-16
74536SUPPL 2023-06-16
74514SUPPL 2023-06-16
74513SUPPL 2023-06-16
70926SUPPL2022-05-03
70897SUPPL2022-05-02
49418SUPPL2017-08-15
49318SUPPL2017-08-10
33874SUPPL2015-05-04
19105SUPPL2015-05-04
11637SUPPL2013-11-20
33873SUPPL2013-10-04
19104SUPPL2013-10-04
19103SUPPL2013-10-04
1515SUPPL2013-10-04
1514SUPPL2013-10-04
11638SUPPL2012-07-13
1513SUPPL2012-06-20
40981SUPPL2009-01-12
40980SUPPL2009-01-12
40979SUPPL2009-01-12
40978SUPPL2009-01-12
40977SUPPL2009-01-12
40976SUPPL2009-01-12
40975SUPPL2009-01-12
40974SUPPL2009-01-12
40973SUPPL2009-01-12
20298SUPPL2009-01-12
20297SUPPL2009-01-12
20296SUPPL2009-01-12
20295SUPPL2009-01-12
20294SUPPL2009-01-12
20293SUPPL2009-01-12
20292SUPPL2009-01-12
20291SUPPL2009-01-12
20290SUPPL2009-01-12
20289SUPPL2009-01-12
19102SUPPL2008-06-03
1512SUPPL2007-05-09
33872SUPPL2007-05-07
53113ORIG1900-01-01
53112ORIG1900-01-01
53111ORIG1900-01-01
53110ORIG1900-01-01
53109ORIG1900-01-01
53108ORIG1900-01-01