Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 78828, held by Jubilant Cadista. Risperidone.
As of Nov 14, 2026, ANDA 78828 (Risperidone), held by Jubilant Cadista, was first approved by FDA on Mar 23, 2009, with 2 approved supplements and 0 published complete response letters.
Risperidone is 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 |
|---|---|---|---|
| Mar 23, 2009 | 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 |
| Jun 30, 2011 | Supplement 2Labeling | Approved | None posted |
| Mar 16, 2011 | Supplement 1Labeling | Approved | None posted |
| Mar 23, 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
