Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 78071, held by Amneal. Risperidone.
As of Nov 13, 2026, ANDA 78071 (Risperidone), held by Amneal, was first approved by FDA on Jun 17, 2009, with 3 approved supplements and 0 published complete response letters.
Risperidone tablets are 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2009 | Original application | Approved | None posted |
| Risperidone0.25MG · tablet;oral | Risperidone | Discontinued |
| Risperidone0.5MG · tablet;oral | Risperidone | Discontinued |
| Risperidone1MG · tablet;oral | Risperidone | Discontinued |
| Risperidone2MG · tablet;oral | Risperidone | Discontinued |
| Risperidone3MG · tablet;oral | Risperidone | Discontinued |
| Risperidone4MG · tablet;oral | Risperidone | Discontinued |
| Aug 13, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 13, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 28, 2011 | Supplement 2Labeling | Approved | None posted |
| Jun 17, 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
