Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 78707, held by Renata. Risperidone.
As of Nov 14, 2026, ANDA 78707 (Risperidone), held by Renata, was first approved by FDA on Dec 29, 2008, with 12 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 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. 1.2 Bipolar Mania Monotherapy Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2008 | Original application | Approved | None posted |
| Risperidone0.25MG · tablet;oral | Risperidone | Rx |
| Risperidone0.5MG · tablet;oral | Risperidone | Rx |
| Risperidone1MG · tablet;oral | Risperidone | Rx |
| Risperidone2MG · tablet;oral | Risperidone | Rx |
| Risperidone3MG · tablet;oral | Risperidone | Rx |
| Risperidone4MG · tablet;oral | Risperidone | Rx |
| May 16, 2025 | Supplement 15Labeling · Standard review | Approved | None posted |
| May 16, 2025 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 16, 2025 | Supplement 20Labeling · Standard review | Approved | None posted |
| May 16, 2025 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 25, 2014 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 18, 2012 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 1, 2012 | Supplement 6Labeling | Approved | None posted |
| Nov 15, 2011 | Supplement 5Labeling | Approved | None posted |
| Aug 25, 2011 | Supplement 4Labeling | Approved | None posted |
| Jun 30, 2011 | Supplement 3Labeling | Approved | None posted |
| Apr 8, 2011 | Supplement 2Labeling | Approved | None posted |
| Feb 19, 2010 | Supplement 1Labeling | Approved | None posted |
| Dec 29, 2008 | 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
