Risperidone

Treats schizophrenia. ANDA 77542, held by Sun Pharm Inds Ltd. Risperidone.

As of Nov 13, 2026, ANDA 77542 (Risperidone), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 6, 2010, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 6, 2010
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Risperidone orally disintegrating tablet 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 orally disintegrating 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 6, 2010	Original application	Approved	None posted

Products

3 strengths and forms


Risperidone0.5MG · tablet, orally disintegrating;oral	Risperidone	Rx
Risperidone1MG · tablet, orally disintegrating;oral	Risperidone	Rx
Risperidone2MG · tablet, orally disintegrating;oral	Risperidone	Rx

All 11 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Sep 28, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Oct 20, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Oct 20, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Oct 20, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Oct 20, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 28, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Oct 29, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jul 27, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Feb 21, 2012	Supplement 1Labeling	Approved	None posted
Aug 6, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 77542
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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