FDA.reportPublic FDA data

Application 019653

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO CYCLEN-21ETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-210.035MG;0.25MGNoNo
002ORTHO CYCLEN-28ETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-197Ortho Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-197Ortho Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-197Ortho Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
52544-247MonoNessanorgestimate and ethinyl estradiolActavis Pharma, IncNDACurrent
52544-248TriNessanorgestimate and ethinyl estradiolActavis Pharma, IncNDACurrent
53002-1563MonoNessanorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.NDACurrent
53002-1564TriNessanorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.NDACurrent
63187-054MonoNessanorgestimate and ethinyl estradiolProficient Rx LPNDACurrent
63187-054MonoNessanorgestimate and ethinyl estradiolProficient Rx LPNDACurrent
68788-7239TriNessanorgestimate and ethinyl estradiolPreferred PharmaceuticalsNDACurrent
68788-7239TriNessanorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc,NDACurrent
76413-166MonoNessanorgestimate and ethinyl estradiolCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49417SUPPL2017-08-15
49317SUPPL2017-08-10
11604SUPPL2015-05-04
1465SUPPL2015-05-04
17522SUPPL2013-10-04
11602SUPPL2013-10-04
1464SUPPL2013-10-04
1463SUPPL2013-10-04
1462SUPPL2013-10-04
11603SUPPL2012-07-13
1461SUPPL2012-06-20
40958SUPPL2009-01-12
40957SUPPL2009-01-12
40956SUPPL2009-01-12
40955SUPPL2009-01-12
40954SUPPL2009-01-12
40953SUPPL2009-01-12
40952SUPPL2009-01-12
40951SUPPL2009-01-12
40950SUPPL2009-01-12
20282SUPPL2009-01-12
20281SUPPL2009-01-12
20280SUPPL2009-01-12
20279SUPPL2009-01-12
20278SUPPL2009-01-12
17521SUPPL2008-06-03
17520SUPPL2007-05-09
11601SUPPL2007-05-07