Seroquel Xr

Treats schizophrenia. NDA 22047, held by Cheplapharm. Quetiapine Fumarate.

As of Nov 14, 2026, NDA 22047 (Seroquel Xr), held by Cheplapharm, was first approved by FDA on May 17, 2007, with 34 approved supplements and 0 published complete response letters.

First approved: May 17, 2007
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SEROQUEL XR is an atypical antipsychotic indicated for the treatment of:

Schizophrenia
Bipolar I disorder, manic, or mixed episodes
Bipolar disorder, depressive episodes
Major depressive disorder, adjunctive therapy with antidepressants 1.1 Schizophrenia SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with SEROQUEL. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below


Apr 30, 2013	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 2, 2009	Supplement 11Efficacy (new indication or use)	Approved	Review Letter Label
Oct 8, 2008	Supplement 8Efficacy (new indication or use)	Approved	Label Letter
Oct 8, 2008	Supplement 7Efficacy (new indication or use)	Approved	Label Letter
Oct 8, 2008	Supplement 6Efficacy (new indication or use)	Approved	Label Letter
May 17, 2007	Original applicationNew dosage form	Approved	Letter Review

Products

5 strengths and forms


Seroquel XrEQ 50MG BASE · tablet, extended release;oral	Quetiapine Fumarate	RxReference drug
Seroquel XrEQ 200MG BASE · tablet, extended release;oral	Quetiapine Fumarate	RxReference drug
Seroquel XrEQ 300MG BASE · tablet, extended release;oral	Quetiapine Fumarate	RxReference drug
Seroquel XrEQ 400MG BASE · tablet, extended release;oral	Quetiapine Fumarate	RxReference drug
Seroquel XrEQ 150MG BASE · tablet, extended release;oral	Quetiapine Fumarate	RxReference drug

All 35 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 48Labeling · Standard review	Approved	Letter Label Medication Guide
Jan 27, 2022	Supplement 46Labeling · Standard review	Approved	Letter Label
Sep 18, 2020	Supplement 44Labeling · Standard review	Approved	Label Letter
Sep 18, 2020	Supplement 41Labeling · Standard review	Approved	Letter
Mar 27, 2020	Supplement 42Labeling · Standard review	Approved	Label Letter
Feb 5, 2020	Supplement 43Labeling	Approved	Label Letter
Aug 26, 2019	Supplement 40Labeling · Standard review	Approved	Letter Label
Nov 29, 2018	Supplement 37Labeling · Standard review	Approved	Letter Label
Nov 29, 2018	Supplement 33Labeling · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 39Labeling	Approved	Letter Label
Jun 17, 2016	Supplement 38Labeling	Approved	Letter Label
Jan 26, 2015	Supplement 36Manufacturing	Approved	Label
Oct 29, 2013	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 30, 2013	Supplement 31Labeling	Approved	Letter Label
Apr 30, 2013	Supplement 30Labeling	Approved	Letter Label
Apr 30, 2013	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 30, 2013	Supplement 26Labeling	Approved	Letter Label
Nov 9, 2011	Supplement 28REMS	Approved	Letter
Jul 8, 2011	Supplement 27Labeling	Approved	Label Letter
Jul 8, 2011	Supplement 23Labeling	Approved	Letter Label
May 17, 2011	Supplement 24Labeling	Approved	Label Letter
Dec 1, 2010	Supplement 25Labeling	Approved	Letter Label
Dec 2, 2009	Supplement 22Labeling	Approved	Letter Label
Dec 2, 2009	Supplement 19Labeling	Approved	Letter Label
Dec 2, 2009	Supplement 17Labeling	Approved	Letter Label
Dec 2, 2009	Supplement 16Labeling	Approved	Letter Label
Dec 2, 2009	Supplement 11Efficacy (new indication or use)	Approved	Review Letter Label
Oct 8, 2008	Supplement 8Efficacy (new indication or use)	Approved	Label Letter
Oct 8, 2008	Supplement 7Efficacy (new indication or use)	Approved	Label Letter
Oct 8, 2008	Supplement 6Efficacy (new indication or use)	Approved	Label Letter
Aug 14, 2008	Supplement 18Labeling · Standard review	Approved	Letter
Aug 11, 2008	Supplement 13Manufacturing	Approved	Label Letter
May 21, 2008	Supplement 9Labeling · Standard review	Approved	Letter
Mar 13, 2008	Supplement 2Manufacturing	Approved	Letter Label
May 17, 2007	Original applicationNew dosage form	Approved	Letter Review

Identifiers

Application: NDA 22047
Drugs@FDA: Overview at FDA
Company: Cheplapharm

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