Risperidone

Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 77328, held by Pharmazone. Risperidone.

As of Nov 13, 2026, ANDA 77328 (Risperidone), held by Pharmazone, was first approved by FDA on Feb 24, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2009
Supplements approved: 14
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 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 15 submissions below

Date	Submission	Status	Documents
Feb 24, 2009	Original application	Approved	Label

Products

6 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
Risperidone0.25MG · tablet, orally disintegrating;oral	Risperidone	Rx

All 15 submissions, including labeling and manufacturing supplements


Sep 22, 2026	Supplement 16Manufacturing	Approved	None posted
Jan 24, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Jan 23, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Jan 23, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Dec 20, 2012	Supplement 10Labeling · Standard review	Approved	None posted
Jul 25, 2012	Supplement 8Labeling	Approved	None posted
Apr 30, 2012	Supplement 9Labeling	Approved	None posted
Oct 26, 2011	Supplement 7Labeling	Approved	None posted
Aug 9, 2011	Supplement 6Labeling	Approved	None posted
May 27, 2011	Supplement 5Labeling	Approved	None posted
Dec 29, 2010	Supplement 4Labeling	Approved	None posted
Nov 30, 2009	Supplement 3Manufacturing	Approved	None posted
Oct 5, 2009	Supplement 2Manufacturing	Approved	None posted
Aug 24, 2009	Supplement 1Labeling	Approved	None posted
Feb 24, 2009	Original application	Approved	Label

Identifiers

Application: ANDA 77328
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