Documents
Application Sponsors
Marketing Status
Application Products
001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ORTHO EVRA | ETHINYL ESTRADIOL; NORELGESTROMIN |
FDA Submissions
TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2001-11-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-08-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-11-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-10-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-06-18 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2004-02-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2004-11-24 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2005-05-06 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2005-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2006-05-17 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2006-09-20 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2008-01-18 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2008-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2009-07-29 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2008-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2008-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2009-09-11 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2009-12-01 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2010-04-13 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2013-04-12 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2011-07-26 | UNKNOWN |
LABELING; Labeling | SUPPL | 39 | AP | 2011-03-23 | UNKNOWN |
LABELING; Labeling | SUPPL | 40 | AP | 2011-12-28 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2013-04-12 | STANDARD |
LABELING; Labeling | SUPPL | 43 | AP | 2012-08-22 | UNKNOWN |
LABELING; Labeling | SUPPL | 44 | AP | 2013-07-01 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 2014-04-11 | STANDARD |
LABELING; Labeling | SUPPL | 47 | AP | 2015-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2017-08-09 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 29 | Null | 7 |
SUPPL | 33 | Null | 6 |
SUPPL | 34 | Null | 6 |
SUPPL | 35 | Null | 6 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 6 |
SUPPL | 39 | Null | 6 |
SUPPL | 40 | Null | 6 |
SUPPL | 41 | Null | 0 |
SUPPL | 43 | Null | 7 |
SUPPL | 44 | Null | 7 |
SUPPL | 46 | Null | 7 |
SUPPL | 47 | Null | 15 |
SUPPL | 48 | Null | 6 |
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 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(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
)
)