Treats schizophrenia. ANDA 208031, held by Lupin. Lurasidone Hydrochloride.
As of Nov 15, 2026, ANDA 208031 (Lurasidone Hydrochloride), held by Lupin, was first approved by FDA on Jan 3, 2019, with 3 approved supplements and 0 published complete response letters.
Lurasidone hydrochloride tablets are 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 3, 2019 | Original application | Approved |
| 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 | Rx |
| May 8, 2025 | Supplement 5Manufacturing | Approved | None posted |
| Apr 15, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 6, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 3, 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
