Lurasidone Hydrochloride

Treats schizophrenia. ANDA 208037, held by Msn. Lurasidone Hydrochloride.

As of Nov 15, 2026, ANDA 208037 (Lurasidone Hydrochloride), held by Msn, was first approved by FDA on Sep 9, 2022, with 0 approved supplements and 0 published complete response letters.

First approved: Sep 9, 2022
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years) ( 1, 14.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Sep 9, 2022	Original application	Approved	None posted

Products

5 strengths and forms


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

Identifiers

Application: ANDA 208037
Drugs@FDA: Overview at FDA
Company: MSN Laboratories

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