Risperdal

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. NDA 20272, held by Janssen Pharms. Risperidone.

As of Nov 14, 2026, NDA 20272 (Risperdal), held by Janssen Pharms, was first approved by FDA on Dec 29, 1993, with 54 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1993
Review: Priority
Supplements approved: 54
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RISPERDAL 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 RISPERDAL (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 RISPERDAL is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 55 submissions below


Aug 2, 2012	Supplement 65Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 22, 2007	Supplement 47Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Aug 22, 2007	Supplement 46Efficacy (new indication or use) · Priority review	Approved	Review Label Letter Pediatric Medical Review
Oct 6, 2006	Supplement 41Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 6, 2006	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 4, 2003	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 4, 2003	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Mar 3, 2002	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter
Oct 17, 1997	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Other Review
Dec 29, 1993	Original applicationNew molecular entity · Priority review	Approved	Review Pediatric DD Summary Review Pediatric CDTL Review Pediatric Medical Review

Products

7 strengths and forms


Risperdal1MG · tablet;oral	Risperidone	RxReference drug
Risperdal2MG · tablet;oral	Risperidone	RxReference drug
Risperdal3MG · tablet;oral	Risperidone	RxReference drug
Risperdal4MG · tablet;oral	Risperidone	RxReference drug
Risperdal5MG · tablet;oral	Risperidone	Discontinued
Risperdal0.5MG · tablet;oral	Risperidone	RxReference drug
Risperdal0.25MG · tablet;oral	Risperidone	RxReference drug

All 55 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 88Labeling · Standard review	Approved	Review Review Letter Label
Dec 2, 2022	Supplement 87Labeling · Standard review	Approved	Label Letter
Feb 12, 2021	Supplement 83Labeling · Standard review	Approved	Label Letter
Feb 5, 2020	Supplement 85Labeling	Approved	Label Letter
Jan 25, 2019	Supplement 82Labeling · Standard review	Approved	Letter Label
Jul 27, 2018	Supplement 80Labeling · Standard review	Approved	Label Letter
Feb 23, 2017	Supplement 78Labeling	Approved	Letter Label
Mar 1, 2016	Supplement 77Labeling · Standard review	Approved	Letter Label
Feb 9, 2016	Supplement 76Manufacturing · Priority review	Approved	None posted
Apr 28, 2014	Supplement 73Labeling · Standard review	Approved	Letter Label
Jun 13, 2013	Supplement 72Manufacturing · Priority review	Approved	None posted
Feb 8, 2013	Supplement 71Manufacturing · Priority review	Approved	None posted
Aug 2, 2012	Supplement 65Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 12, 2012	Supplement 67Labeling · Standard review	Approved	Letter
Sep 24, 2011	Supplement 66Labeling · Standard review	Approved	Label Letter
Sep 24, 2011	Supplement 60Labeling · Priority review	Approved	Label Letter
Aug 24, 2011	Supplement 59Labeling · Standard review	Approved	Letter Label
Jun 15, 2011	Supplement 64Labeling · Standard review	Approved	Letter Label
Dec 1, 2010	Supplement 63Labeling	Approved	Letter Label
Aug 30, 2010	Supplement 62Labeling	Approved	Letter Label
Aug 30, 2010	Supplement 61Labeling	Approved	Letter Label
Aug 30, 2010	Supplement 58Labeling	Approved	Letter Label
Aug 30, 2010	Supplement 55Labeling · Standard review	Approved	Letter Label
Jul 19, 2009	Supplement 56Labeling	Approved	Letter Label
Aug 14, 2008	Supplement 54Labeling · Standard review	Approved	Letter
Aug 22, 2007	Supplement 47Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Aug 22, 2007	Supplement 46Efficacy (new indication or use) · Priority review	Approved	Review Label Letter Pediatric Medical Review
Oct 6, 2006	Supplement 41Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 6, 2006	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 17, 2005	Supplement 42Labeling · Standard review	Approved	Label Letter
Dec 4, 2003	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 4, 2003	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 21, 2003	Supplement 35Labeling · Standard review	Approved	Letter
Oct 29, 2003	Supplement 25Labeling · Standard review	Approved	Letter
Sep 10, 2003	Supplement 33Labeling · Standard review	Approved	Review Letter
Nov 19, 2002	Supplement 24Labeling · Standard review	Approved	Letter
Jul 9, 2002	Supplement 23Manufacturing · Priority review	Approved	None posted
Mar 3, 2002	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter
Oct 22, 2001	Supplement 20Manufacturing · Priority review	Approved	None posted
Sep 28, 2001	Supplement 21Manufacturing · Priority review	Approved	None posted
Jul 20, 2001	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 27, 1999	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 2, 1999	Supplement 9Labeling · Standard review	Approved	Letter Label
May 10, 1999	Supplement 14Manufacturing · Priority review	Approved	None posted
Jan 27, 1999	Supplement 13Manufacturing · Priority review	Approved	None posted
Oct 26, 1998	Supplement 12Manufacturing · Priority review	Approved	None posted
May 13, 1998	Supplement 10Manufacturing · Priority review	Approved	None posted
Apr 2, 1998	Supplement 6Labeling · Standard review	Approved	None posted
Oct 17, 1997	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Other Review
Mar 7, 1996	Supplement 5Manufacturing · Priority review	Approved	Review
Feb 28, 1996	Supplement 4Labeling · Standard review	Approved	Review
Apr 12, 1995	Supplement 3Labeling · Standard review	Approved	None posted
Dec 22, 1994	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 24, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Dec 29, 1993	Original applicationNew molecular entity · Priority review	Approved	Review Pediatric DD Summary Review Pediatric CDTL Review Pediatric Medical Review

Show all 55

Identifiers

Application: NDA 20272
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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