Treats schizophrenia. ANDA 211220, held by Nanomi. Risperidone.
As of Nov 13, 2026, ANDA 211220 (Risperidone), held by Nanomi, was first approved by FDA on Sep 2, 2025, with 0 approved supplements and 0 published complete response letters.
Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: for the treatment of schizophrenia. as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. 1.1 Schizophrenia Risperidone for extended-release injectable suspension is indicated for the treatment of schizophrenia. 1.2 Bipolar Disorder Risperidone for extended-release injectable suspension is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 2025 | Original application | Approved | None posted |
| Risperidone25MG/VIAL · powder;intramuscular | Risperidone | Rx |
| Risperidone37.5MG/VIAL · powder;intramuscular | Risperidone | Rx |
| Risperidone50MG/VIAL · powder;intramuscular | Risperidone | Rx |
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
