ANDA 78036, held by Sun Pharm Inds Inc. Risperidone.
As of Nov 14, 2026, ANDA 78036 (Risperidone), held by Sun Pharm Inds Inc, was first approved by FDA on Mar 10, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 10, 2014 | 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
