Risperidone

Treats schizophrenia. ANDA 91384, held by Amneal Pharms. Risperidone.

As of Nov 13, 2026, ANDA 91384 (Risperidone), held by Amneal Pharms, was first approved by FDA on May 25, 2011, with 12 approved supplements and 0 published complete response letters.

First approved: May 25, 2011
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Risperidone oral solution 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 13 submissions below

Date	Submission	Status	Documents
May 25, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Nov 4, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Sep 9, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Aug 31, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Nov 28, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Dec 19, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jan 30, 2012	Supplement 2Labeling	Approved	None posted
Nov 8, 2011	Supplement 1Labeling	Approved	None posted
May 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91384
Drugs@FDA: Overview at FDA
Company: Amneal 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