Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INTRAMUSCULAR | 25MG/VIAL | 1 | RISPERDAL CONSTA | RISPERIDONE |
| 002 | INJECTABLE;INTRAMUSCULAR | 37.5MG/VIAL | 1 | RISPERDAL CONSTA | RISPERIDONE |
| 003 | INJECTABLE;INTRAMUSCULAR | 50MG/VIAL | 1 | RISPERDAL CONSTA | RISPERIDONE |
| 004 | INJECTABLE;INTRAMUSCULAR | 12.5MG/VIAL | 1 | RISPERDAL CONSTA | RISPERIDONE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2005-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2006-09-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2007-04-12 | UNKNOWN |
| LABELING; Labeling | SUPPL | 20 | AP | 2007-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2008-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2008-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2008-10-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2009-05-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2008-08-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2009-05-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 31 | AP | 2010-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2011-12-07 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2009-07-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 35 | AP | 2010-08-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 36 | AP | 2011-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2011-09-24 | |
| LABELING; Labeling | SUPPL | 38 | AP | 2010-08-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 39 | AP | 2010-08-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2010-12-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 41 | AP | 2011-12-07 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2011-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2011-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2012-03-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2013-10-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2013-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2013-07-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2013-10-22 | |
| LABELING; Labeling | SUPPL | 51 | AP | 2014-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2014-06-05 | |
| LABELING; Labeling | SUPPL | 54 | AP | 2016-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2016-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2017-02-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 58 | AP | 2018-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2018-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2019-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2021-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2019-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2020-02-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 64 | TA | 2020-07-23 | STANDARD |
Submissions Property Types
| SUPPL | 25 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 36 | Null | 15 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 58 | Null | 7 |
| SUPPL | 60 | Null | 7 |
| SUPPL | 61 | Null | 7 |
| SUPPL | 63 | Null | 15 |
| SUPPL | 64 | Null | 15 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21346
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RISPERDAL CONSTA","activeIngredients":"RISPERIDONE","strength":"25MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"RISPERDAL CONSTA","activeIngredients":"RISPERIDONE","strength":"37.5MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL CONSTA","activeIngredients":"RISPERIDONE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"RISPERDAL CONSTA","activeIngredients":"RISPERIDONE","strength":"12.5MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/12\/2021","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020272Orig1s083,020588Orig1s071,021444Orig1s057,021346Orig1s061lbl.pdf#page=60\"}]","notes":""},{"actionDate":"02\/05\/2020","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021346s063lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021346s060lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021346s058lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021346s056lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2016","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020272s077,020588s065,021346s055,021444s051lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2014","submission":"SUPPL-52","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021346s052lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"04\/28\/2014","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021346s051lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2011","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021346s032s041lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2011","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021346s032s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2011","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021346s037s043lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2011","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021346s037s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2011","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021346s036lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2011","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021346s042lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020272s063,020588s051,021346s040,021444s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021346_s31_s35_s38_s39lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021346_s31_s35_s38_s39lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-35","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021346_s31_s35_s38_s39lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2010","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021346_s31_s35_s38_s39lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020272s056,020588s044,021346s033,021444s03lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2009","submission":"SUPPL-28","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021346s025s028lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2009","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021346s025s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021346s021s022s023s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021346s021s022s023s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021346s021s022s023s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021346s021s022s023s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2007","submission":"SUPPL-15","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021346s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021346s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2006","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021346s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2005","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020272s042,020588s030,021444s016,021346s010lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RISPERDAL CONSTA","submission":"RISPERIDONE","actionType":"25MG\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL CONSTA","submission":"RISPERIDONE","actionType":"37.5MG\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL CONSTA","submission":"RISPERIDONE","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RISPERDAL CONSTA","submission":"RISPERIDONE","actionType":"12.5MG\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-02-12
)
)