Treats schizophrenia. NDA 21346, held by Janssen Pharms. Risperidone.
As of Nov 15, 2026, NDA 21346 (Risperdal Consta), held by Janssen Pharms, was first approved by FDA on Oct 29, 2003, with 43 approved supplements and 0 published complete response letters.
RISPERDAL CONSTA is an atypical antipsychotic indicated: for the treatment of schizophrenia. as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. 1.1 Schizophrenia RISPERDAL CONSTA (risperidone) is indicated for the treatment of schizophrenia. 1.2 Bipolar Disorder RISPERDAL CONSTA is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.
| May 15, 2009 | Supplement 28Efficacy (new indication or use) | Approved | |
| May 15, 2009 | Supplement 25Efficacy (new indication or use) | Approved | |
| Apr 12, 2007 | Supplement 15Efficacy (new indication or use) | Approved | |
| Oct 29, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Risperdal Consta25MG/VIAL · powder;intramuscular | Risperidone | RxReference drug |
| Risperdal Consta37.5MG/VIAL · powder;intramuscular | Risperidone | RxReference drug |
| Risperdal Consta50MG/VIAL · powder;intramuscular | Risperidone | RxReference drug |
| Risperdal Consta12.5MG/VIAL · powder;intramuscular | Risperidone | RxReference drug |
| Jan 22, 2025 | Supplement 65Labeling · Standard review | Approved | |
| Feb 12, 2021 | Supplement 61Labeling · Standard review | Approved | |
| Jan 7, 2021 | Supplement 64Labeling · Standard review | Approved | |
| Feb 5, 2020 | Supplement 63Labeling | Approved | |
| Nov 22, 2019 | Supplement 62Labeling · Standard review | Approved | |
| Jan 25, 2019 | Supplement 60Labeling · Standard review | Approved | |
| Jul 27, 2018 | Supplement 58Labeling · Standard review | Approved | |
| Apr 12, 2018 | Supplement 59Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 56Labeling | Approved | |
| Nov 18, 2016 | Supplement 54Labeling · Standard review | Approved | |
| Mar 1, 2016 | Supplement 55Labeling · Standard review | Approved | |
| Jun 5, 2014 | Supplement 52Manufacturing | Approved | |
| Apr 28, 2014 | Supplement 51Labeling · Standard review | Approved | |
| Oct 22, 2013 | Supplement 50Manufacturing | Approved | |
| Oct 10, 2013 | Supplement 47Manufacturing | Approved | None posted |
| Jul 18, 2013 | Supplement 49Manufacturing | Approved | |
| Feb 26, 2013 | Supplement 48Manufacturing | Approved | |
| Mar 12, 2012 | Supplement 44Labeling · Standard review | Approved | |
| Dec 7, 2011 | Supplement 41Labeling · Standard review | Approved | |
| Dec 7, 2011 | Supplement 32Labeling · Standard review | Approved | |
| Sep 24, 2011 | Supplement 43Labeling · Standard review | Approved | |
| Sep 24, 2011 | Supplement 37Labeling | Approved | |
| Aug 24, 2011 | Supplement 36Labeling · Standard review | Approved | |
| Jun 15, 2011 | Supplement 42Labeling · Standard review | Approved | |
| Dec 1, 2010 | Supplement 40Labeling | Approved | |
| Aug 30, 2010 | Supplement 39Labeling | Approved | |
| Aug 30, 2010 | Supplement 38Labeling | Approved | |
| Aug 30, 2010 | Supplement 35Labeling | Approved | |
| Aug 30, 2010 | Supplement 31Labeling · Standard review | Approved | |
| Jul 19, 2009 | Supplement 33Labeling | Approved | |
| May 15, 2009 | Supplement 28Efficacy (new indication or use) | Approved | |
| May 15, 2009 | Supplement 25Efficacy (new indication or use) | Approved | |
| Oct 8, 2008 | Supplement 26Labeling · Standard review | Approved | |
| Oct 8, 2008 | Supplement 23Labeling · Standard review | Approved | |
| Oct 8, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Oct 8, 2008 | Supplement 21Labeling · Standard review | Approved | |
| Aug 14, 2008 | Supplement 27Labeling · Standard review | Approved | |
| Apr 12, 2007 | Supplement 15Efficacy (new indication or use) | Approved | |
| Mar 9, 2007 | Supplement 20Labeling · Standard review | Approved | |
| Oct 20, 2006 | Supplement 9Labeling · Standard review | Approved | |
| Sep 20, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Jul 31, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Aug 17, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Oct 29, 2003 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
