JANSSEN PHARMS FDA Approval NDA 021180

NDA 021180

JANSSEN PHARMS

FDA Drug Application

Application #021180

Documents

Letter2004-03-02
Letter2004-12-02
Letter2005-05-17
Letter2005-11-18
Letter2009-11-10
Letter2008-11-03
Letter2009-11-10
Letter2010-01-25
Letter2010-04-19
Letter2013-07-03
Letter2015-10-23
Label2005-05-17
Label2006-09-20
Label2009-08-13
Label2008-11-07
Label2009-09-17
Label2009-12-02
Label2010-04-19
Label2011-12-28
Label2012-08-22
Label2014-04-14
Review2001-11-20
Review2008-08-01
Review2006-07-11
Letter2001-11-20
Letter2006-05-21
Letter2006-09-20
Letter2008-11-03
Letter2008-11-03
Letter2011-07-28
Letter2011-03-25
Letter2012-01-03
Letter2012-08-24
Letter2014-04-14
Label2001-11-20
Label2005-11-10
Label2008-01-18
Label2008-11-07
Label2008-11-07
Label2011-08-12
Label2011-03-28
Label2013-07-03
Label2015-10-26
Review2008-08-01
Review2006-07-11
Review2007-06-29
Review2008-07-31
Other Important Information from FDA2006-09-22
Label2017-08-09
Letter2017-08-15

Application Sponsors

NDA 021180JANSSEN PHARMS

Marketing Status

Discontinued001

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ORTHO EVRAETHINYL ESTRADIOL; NORELGESTROMIN

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2001-11-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-08-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-06-18STANDARD
LABELING; LabelingSUPPL8AP2004-02-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2004-11-24STANDARD
LABELING; LabelingSUPPL15AP2005-05-06STANDARD
LABELING; LabelingSUPPL19AP2005-11-10STANDARD
LABELING; LabelingSUPPL20AP2006-05-17STANDARD
LABELING; LabelingSUPPL22AP2006-09-20STANDARD
LABELING; LabelingSUPPL26AP2008-01-18STANDARD
LABELING; LabelingSUPPL28AP2008-10-30STANDARD
LABELING; LabelingSUPPL29AP2009-07-29STANDARD
LABELING; LabelingSUPPL30AP2008-10-30STANDARD
LABELING; LabelingSUPPL31AP2008-10-30STANDARD
LABELING; LabelingSUPPL33AP2009-09-11STANDARD
LABELING; LabelingSUPPL34AP2009-12-01STANDARD
LABELING; LabelingSUPPL35AP2010-04-13UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2013-04-12STANDARD
LABELING; LabelingSUPPL38AP2011-07-26UNKNOWN
LABELING; LabelingSUPPL39AP2011-03-23UNKNOWN
LABELING; LabelingSUPPL40AP2011-12-28UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2013-04-12STANDARD
LABELING; LabelingSUPPL43AP2012-08-22UNKNOWN
LABELING; LabelingSUPPL44AP2013-07-01STANDARD
LABELING; LabelingSUPPL46AP2014-04-11STANDARD
LABELING; LabelingSUPPL47AP2015-10-22STANDARD
LABELING; LabelingSUPPL48AP2017-08-09STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL14Null0
SUPPL29Null7
SUPPL33Null6
SUPPL34Null6
SUPPL35Null6
SUPPL37Null0
SUPPL38Null6
SUPPL39Null6
SUPPL40Null6
SUPPL41Null0
SUPPL43Null7
SUPPL44Null7
SUPPL46Null7
SUPPL47Null15
SUPPL48Null6

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21180
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO EVRA","activeIngredients":"ETHINYL ESTRADIOL; NORELGESTROMIN","strength":"0.035MG\/24HR;0.15MG\/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021180s048lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2015","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021180s047lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2014","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021180Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2013","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021180s044lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2012","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021180s043lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2011","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021180s040lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2011","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021180s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2011","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021180s039lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2010","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021180s035lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2009","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021180s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2009","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021180s033lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2009","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021180s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2008","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021180s028s030s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2008","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021180s028s030s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2008","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021180s028s030s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2008","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021180s026lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2006","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021180s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2005","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021180s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021180s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21180lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORTHO EVRA","submission":"ETHINYL ESTRADIOL; NORELGESTROMIN","actionType":"0.035MG\/24HR;0.15MG\/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)
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