Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 79059, held by Tris Pharma Inc. Risperidone.
As of Nov 14, 2026, ANDA 79059 (Risperidone), held by Tris Pharma Inc, was first approved by FDA on Dec 12, 2012, with 7 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Risperidone1MG/ML · solution;oral | Risperidone | Rx |
| May 12, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 12, 2012 | 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
