Risperidone

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 78909, held by Pharmazone. Risperidone.

As of Nov 13, 2026, ANDA 78909 (Risperidone), held by Pharmazone, was first approved by FDA on Jul 29, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2009
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Risperidone is an atypical antipsychotic agent 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 12 submissions below

Date	Submission	Status	Documents
Jul 29, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


May 28, 2025	Supplement 17Labeling · Standard review	Approved	None posted
May 28, 2025	Supplement 16Labeling · Standard review	Approved	None posted
May 28, 2025	Supplement 13Labeling · Standard review	Approved	None posted
May 28, 2025	Supplement 12Labeling · Standard review	Approved	None posted
May 28, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Mar 1, 2012	Supplement 9Labeling	Approved	None posted
Nov 10, 2011	Supplement 8Labeling	Approved	None posted
Nov 10, 2011	Supplement 7Labeling	Approved	None posted
Nov 10, 2011	Supplement 6Labeling	Approved	None posted
Apr 25, 2011	Supplement 3Labeling	Approved	None posted
Jan 11, 2011	Supplement 2Labeling	Approved	None posted
Jul 29, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78909
Drugs@FDA: Overview at FDA
Company: Pharmazone

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