Risperidone

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 77493, held by Prinston Inc. Risperidone.

As of Nov 13, 2026, ANDA 77493 (Risperidone), held by Prinston Inc, was first approved by FDA on Nov 29, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 29, 2011
Supplements approved: 6
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 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 29, 2011	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 7 submissions, including labeling and manufacturing supplements


Mar 5, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Oct 25, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Nov 17, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Nov 17, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jan 26, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Jan 26, 2017	Supplement 3Labeling · Standard review	Approved	None posted
Nov 29, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77493
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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