Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 77494, held by Ph Health. Risperidone.
As of Nov 14, 2026, ANDA 77494 (Risperidone), held by Ph Health, was first approved by FDA on Apr 30, 2009, with 13 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2009 | Original application | Approved | None posted |
| Risperidone0.25MG · tablet, orally disintegrating;oral | Risperidone | Rx |
| 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 |
| Risperidone1MG · tablet, orally disintegrating; oral | Risperidone | Rx |
| Jun 8, 2026 | Supplement 27Labeling · Standard review | Approved | None posted |
| Aug 31, 2022 | Supplement 18Labeling · Standard review | Approved | None posted |
| Aug 31, 2022 | Supplement 20Labeling · Standard review | Approved | None posted |
| Dec 9, 2019 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 9, 2019 | Supplement 16Labeling · Standard review | Approved | None posted |
| Sep 22, 2015 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 30, 2013 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 10, 2012 | Supplement 10Labeling | Approved | None posted |
| Feb 21, 2012 | Supplement 9Labeling | Approved | None posted |
| May 27, 2011 | Supplement 8Labeling | Approved | None posted |
| Dec 29, 2010 | Supplement 7Labeling | Approved | None posted |
| Oct 26, 2009 | Supplement 4Manufacturing | Approved | None posted |
| Oct 19, 2009 | Supplement 3Labeling | Approved | None posted |
| Apr 30, 2009 | Original application | Approved | None posted |
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
