Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. ANDA 201003, held by Ajanta Pharma Ltd. Risperidone.
As of Nov 13, 2026, ANDA 201003 (Risperidone), held by Ajanta Pharma Ltd, was first approved by FDA on Aug 24, 2011, with 13 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 |
|---|---|---|---|
| Aug 24, 2011 | 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 12, 2024 | Supplement 45Labeling · Standard review | Approved | None posted |
| Jun 12, 2024 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jun 12, 2024 | Supplement 19Labeling · Standard review | Approved | None posted |
| Nov 12, 2019 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 12, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 12, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 8, 2017 | Supplement 8Manufacturing | Approved | None posted |
| Feb 1, 2017 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 27, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 27, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 17, 2015 | Supplement 6Manufacturing | Approved | None posted |
| Dec 31, 2012 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 25, 2012 | Supplement 1Labeling | Approved | None posted |
| Aug 24, 2011 | 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
