Risperidone

Treats schizophrenia. ANDA 76440, held by Ani Pharms. Risperidone.

As of Nov 14, 2026, ANDA 76440 (Risperidone), held by Ani Pharms, was first approved by FDA on Jan 30, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 30, 2009
Supplements approved: 8
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 9 submissions below

Date	Submission	Status	Documents
Jan 30, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Sep 24, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Jul 14, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jul 14, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jul 14, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Sep 27, 2011	Supplement 5Labeling	Approved	None posted
Jan 11, 2011	Supplement 3Labeling	Approved	None posted
Apr 27, 2010	Supplement 2Labeling	Approved	None posted
Dec 15, 2009	Supplement 1Labeling	Approved	None posted
Jan 30, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 76440
Drugs@FDA: Overview at FDA
Company: ANI 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