Treats schizophrenia. ANDA 214068, held by Teva Pharms USA Inc. Risperidone.
As of Nov 13, 2026, ANDA 214068 (Risperidone), held by Teva Pharms USA Inc, was first approved by FDA on Dec 5, 2023, 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 |
|---|---|---|---|
| Dec 5, 2023 | Original application | Approved |
| Risperidone12.5MG/VIAL · powder;intramuscular | Risperidone | Rx |
| 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
