Risperidone

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 78452, held by Aurobindo Pharma Ltd. Risperidone.

As of Nov 13, 2026, ANDA 78452 (Risperidone), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 4, 2009, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 4, 2009
Supplements approved: 13
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 oral solution 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Sep 4, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Risperidone1MG/ML · solution;oral	Risperidone	Rx

All 14 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 17Labeling · Standard review	Approved	None posted
Aug 9, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Aug 8, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jul 13, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jul 13, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Jul 13, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Jul 13, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jul 13, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Apr 23, 2015	Supplement 5Manufacturing	Approved	None posted
Oct 22, 2012	Supplement 4Labeling · Standard review	Approved	None posted
Jan 30, 2012	Supplement 3Labeling	Approved	None posted
Nov 10, 2011	Supplement 2Labeling	Approved	None posted
Apr 19, 2011	Supplement 1Labeling	Approved	None posted
Sep 4, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78452
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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