FDA.reportPublic FDA data

Application 021180

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO EVRAETHINYL ESTRADIOL; NORELGESTROMINFILM, EXTENDED RELEASE;TRANSDERMAL0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49371SUPPL2017-08-15
49299SUPPL2017-08-09
36306SUPPL2015-10-26
4583SUPPL2015-10-23
27014SUPPL2014-04-14
14596SUPPL2014-04-14
36305SUPPL2013-07-03
4582SUPPL2013-07-03
27013SUPPL2012-08-24
14595SUPPL2012-08-22
27012SUPPL2012-01-03
14594SUPPL2011-12-28
36303SUPPL2011-08-12
27010SUPPL2011-07-28
36304SUPPL2011-03-28
27011SUPPL2011-03-25
14593SUPPL2010-04-19
4581SUPPL2010-04-19
4580SUPPL2010-01-25
14592SUPPL2009-12-02
4579SUPPL2009-11-10
4577SUPPL2009-11-10
14591SUPPL2009-09-17
14589SUPPL2009-08-13
36302SUPPL2008-11-07
36301SUPPL2008-11-07
14590SUPPL2008-11-07
27009SUPPL2008-11-03
27008SUPPL2008-11-03
4578SUPPL2008-11-03
42004SUPPL2008-08-01
21493SUPPL2008-08-01
42007SUPPL2008-07-31
36300SUPPL2008-01-18
42006SUPPL2007-06-29
44102ORIG2006-09-22
27007SUPPL2006-09-20
14588SUPPL2006-09-20
42005SUPPL2006-07-11
21494SUPPL2006-07-11
27006SUPPL2006-05-21
4576SUPPL2005-11-18
36299SUPPL2005-11-10
14587SUPPL2005-05-17
4575SUPPL2005-05-17
4574SUPPL2004-12-02
4573SUPPL2004-03-02
36298ORIG2001-11-20
27005ORIG2001-11-20
21492ORIG2001-11-20