Documents
Application Sponsors
| NDA 202379 | JANSSEN BIOTECH | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG | 1 | ZYTIGA | ABIRATERONE ACETATE |
| 002 | TABLET;ORAL | 500MG | 1 | ZYTIGA | ABIRATERONE ACETATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2011-04-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-07-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2012-09-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2012-12-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2013-06-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-02-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2014-05-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2014-04-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2014-04-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-11-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2015-01-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 2015-01-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2015-03-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2015-03-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 2015-05-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2015-08-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2016-05-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2018-02-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2018-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2019-06-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2019-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2020-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2020-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2021-08-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 31 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 35 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
JANSSEN BIOTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 202379
[companyName] => JANSSEN BIOTECH
[docInserts] => ["",""]
[products] => [{"drugName":"ZYTIGA","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZYTIGA","activeIngredients":"ABIRATERONE ACETATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202379s031s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202379s031s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202379s031s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202379s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2015","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202379s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202379s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-New 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[originalApprovals] => [{"actionDate":"04\/28\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202379lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202379s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202379Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202379Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202379s031s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202379Orig1s031,s033ltr.pdf\"}]","notes":">"},{"actionDate":"10\/02\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202379s031s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202379Orig1s031,s033ltr.pdf\"}]","notes":">"},{"actionDate":"06\/03\/2019","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202379s027s028lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/03\/2019","submission":"SUPPL-27","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202379s027s028lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/25\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202379s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202379Orig1s025ltr.pdf\"}]","notes":">"},{"actionDate":"02\/07\/2018","submission":"SUPPL-24","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202379s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202379Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"05\/17\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202379s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202379Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"12\/10\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202379Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"08\/18\/2015","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/20\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202379Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2015","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/20\/2015","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202379Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"01\/23\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202379s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202379Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"01\/20\/2015","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/16\/2014","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2014","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/01\/2014","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/13\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202379s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202379Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/07\/2014","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/12\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202379s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202379Orig1s007ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/review\\\/2018\\\/202379Orig1s007.pdf\"}]","notes":">"},{"actionDate":"06\/17\/2013","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/202379Orig1s006.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/10\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202379s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202379Orig1s005ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202379Orig1s005.pdf\"}]","notes":">"},{"actionDate":"09\/17\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202379s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202379Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/03\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202379s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202379s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-10-02
)
)