Manages schizophrenia. ANDA 211642, held by Novitium Pharma. Thiothixene.
As of Nov 13, 2026, ANDA 211642 (Thiothixene), held by Novitium Pharma, was first approved by FDA on Apr 5, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE 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 |
|---|---|---|---|
| Apr 5, 2019 | Original application | Approved |
| 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 21Labeling · Standard review | Approved | None posted |
| Apr 5, 2019 | Original application | Approved |
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
