Risperidone

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 79088, held by Torrent Pharms. Risperidone.

As of Nov 13, 2026, ANDA 79088 (Risperidone), held by Torrent Pharms, was first approved by FDA on Oct 30, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 30, 2008
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 tablets are 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 tablets are 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 19 submissions below

Date	Submission	Status	Documents
Oct 30, 2008	Original application	Approved	None posted

Products

6 strengths and forms


Risperidone0.25MG · tablet;oral	Risperidone	Rx
Risperidone0.5MG · tablet;oral	Risperidone	Rx
Risperidone1MG · tablet;oral	Risperidone	Rx
Risperidone2MG · tablet;oral	Risperidone	Rx
Risperidone3MG · tablet;oral	Risperidone	Rx
Risperidone4MG · tablet;oral	Risperidone	Rx

All 19 submissions, including labeling and manufacturing supplements


Jun 17, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 13Labeling · Standard review	Approved	None posted
Jan 3, 2012	Supplement 12Labeling	Approved	None posted
Jan 3, 2012	Supplement 11Labeling	Approved	None posted
Aug 26, 2011	Supplement 10Labeling	Approved	None posted
Aug 16, 2011	Supplement 8Labeling	Approved	None posted
May 27, 2011	Supplement 6Labeling	Approved	None posted
Dec 29, 2010	Supplement 5Labeling	Approved	None posted
Jun 29, 2010	Supplement 4Labeling	Approved	None posted
Dec 15, 2009	Supplement 2Labeling	Approved	None posted
Dec 2, 2009	Supplement 3Manufacturing	Approved	None posted
Oct 30, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 79088
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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