Risperidone

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 90839, held by Jubilant Generics. Risperidone.

As of Nov 13, 2026, ANDA 90839 (Risperidone), held by Jubilant Generics, was first approved by FDA on Nov 4, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2011
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Risperidone orally disintegrating tablets are 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 9 submissions below

Date	Submission	Status	Documents
Nov 4, 2011	Original application	Approved	None posted

Products

5 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
Risperidone3MG · tablet, orally disintegrating;oral	Risperidone	Rx
Risperidone4MG · tablet, orally disintegrating;oral	Risperidone	Rx

All 9 submissions, including labeling and manufacturing supplements


Sep 18, 2023	Supplement 21Labeling · Standard review	Approved	None posted
Sep 18, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Dec 22, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Dec 22, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Dec 22, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Oct 22, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jul 24, 2012	Supplement 1Labeling	Approved	None posted
Nov 4, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90839
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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