Treats schizophrenia. ANDA 208066, held by Sun Pharm. Lurasidone Hydrochloride.
As of Nov 15, 2026, ANDA 208066 (Lurasidone Hydrochloride), held by Sun Pharm, was first approved by FDA on Jan 4, 2019, with 2 approved supplements and 0 published complete response letters.
Lurasidone hydrochloride tablet is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression). Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression). Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) (1, 14.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 2019 | Original application | Approved | None posted |
| Lurasidone Hydrochloride20MG · tablet;oral | Lurasidone Hydrochloride | Rx |
| Lurasidone Hydrochloride40MG · tablet;oral | Lurasidone Hydrochloride | Rx |
| Lurasidone Hydrochloride60MG · tablet;oral | Lurasidone Hydrochloride | Rx |
| Lurasidone Hydrochloride80MG · tablet;oral | Lurasidone Hydrochloride | Rx |
| Lurasidone Hydrochloride120MG · tablet;oral | Lurasidone Hydrochloride | Discontinued |
| Aug 12, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 12, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 4, 2019 | 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
