Lurasidone Hydrochloride

Treats schizophrenia. ANDA 212091, held by Chartwell Rx. Lurasidone Hydrochloride.

As of Nov 15, 2026, ANDA 212091 (Lurasidone Hydrochloride), held by Chartwell Rx, was first approved by FDA on Dec 28, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 28, 2020
Review: Standard
Supplements approved: 2
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; all 3 submissions below

Date	Submission	Status	Documents
Dec 28, 2020	Original application	Approved	Letter

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

All 3 submissions, including labeling and manufacturing supplements


Feb 24, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Feb 24, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Dec 28, 2020	Original application	Approved	Letter

Identifiers

Application: ANDA 212091
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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