ANDA 77784, held by Ratiopharm. Risperidone.
As of Nov 14, 2026, ANDA 77784 (Risperidone), held by Ratiopharm, was first approved by FDA on Jun 8, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2010 | Original application | Approved | None posted |
| Risperidone0.25MG · tablet;oral | Risperidone | Discontinued |
| Risperidone0.5MG · tablet;oral | Risperidone | Discontinued |
| Risperidone1MG · tablet;oral | Risperidone | Discontinued |
| Risperidone2MG · tablet;oral | Risperidone | Discontinued |
| Risperidone3MG · tablet;oral | Risperidone | Discontinued |
| Risperidone4MG · tablet;oral | Risperidone | Discontinued |
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
