Manages schizophrenia. ANDA 215456, held by Amneal. Thiothixene.
As of Nov 13, 2026, ANDA 215456 (Thiothixene), held by Amneal, was first approved by FDA on Feb 28, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thiothixene1MG · capsule;oral | Thiothixene | Rx |
| Thiothixene2MG · capsule;oral | Thiothixene | Rx |
| Thiothixene5MG · capsule;oral | Thiothixene | Rx |
| Thiothixene10MG · capsule;oral | Thiothixene | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 28, 2022 | 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
