Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. NDA 20588, held by Janssen Pharms. Risperidone.
As of Nov 13, 2026, NDA 20588 (Risperdal), held by Janssen Pharms, was first approved by FDA on Jun 10, 1996, with 43 approved supplements and 0 published complete response letters.
Risperidone is an atypical antipsychotic indicated for: Treatment of schizophrenia As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder Treatment of irritability associated with autistic disorder 1.1 Schizophrenia Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults. 1.2 Bipolar Mania Monotherapy Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2012 | Supplement 53Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2007 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | |
| Aug 22, 2007 | Supplement 36Efficacy (new indication or use) · Priority review | Approved | |
| Oct 6, 2006 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Dec 4, 2003 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 4, 2003 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 1997 | Supplement 2Efficacy (new indication or use) | Approved | |
| Jun 10, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Risperdal1MG/ML · solution;oral | Risperidone | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2025 | Supplement 74Labeling · Standard review | Approved | |
| Mar 11, 2022 | Supplement 73Labeling · Standard review | Approved | |
| Feb 12, 2021 | Supplement 71Labeling · Standard review | Approved | |
| Feb 5, 2020 | Supplement 72Labeling | Approved | |
| Jan 25, 2019 | Supplement 70Labeling · Standard review | Approved | |
| Jul 27, 2018 | Supplement 68Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 66Labeling | Approved | |
| Mar 1, 2016 | Supplement 65Labeling · Standard review | Approved | |
| Apr 28, 2014 | Supplement 62Labeling · Standard review | Approved | |
| Aug 2, 2012 | Supplement 53Efficacy (new indication or use) · Standard review | Approved | |
| Mar 12, 2012 | Supplement 55Labeling · Standard review | Approved | |
| Sep 24, 2011 | Supplement 48Labeling · Standard review | Approved | |
| Sep 24, 2011 | Supplement 54Labeling · Standard review | Approved | |
| Aug 24, 2011 | Supplement 47Labeling · Standard review | Approved | |
| Jun 15, 2011 | Supplement 52Labeling · Standard review | Approved | |
| Dec 1, 2010 | Supplement 51Labeling | Approved | |
| Aug 30, 2010 | Supplement 43Labeling · Standard review | Approved | |
| Aug 30, 2010 | Supplement 46Labeling | Approved | |
| Aug 30, 2010 | Supplement 49Labeling | Approved | |
| Aug 30, 2010 | Supplement 50Labeling | Approved | |
| Jul 19, 2009 | Supplement 44Labeling | Approved | |
| Aug 14, 2008 | Supplement 42Labeling · Standard review | Approved | |
| Aug 22, 2007 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | |
| Aug 22, 2007 | Supplement 36Efficacy (new indication or use) · Priority review | Approved | |
| Oct 6, 2006 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Aug 17, 2005 | Supplement 30Labeling · Standard review | Approved | |
| Dec 4, 2003 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 4, 2003 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2003 | Supplement 23Labeling · Standard review | Approved | |
| Oct 29, 2003 | Supplement 16Labeling · Standard review | Approved | |
| Sep 10, 2003 | Supplement 21Labeling · Standard review | Approved | |
| Nov 19, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Mar 3, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 2001 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 2, 1999 | Supplement 5Labeling · Standard review | Approved | |
| Oct 8, 1998 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1998 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 19, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 17, 1997 | Supplement 2Efficacy (new indication or use) | Approved | |
| Apr 15, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
