← FDA DRUG APPROVALS

FDA NDA · NDA022047

SEROQUEL XR

quetiapine

Sponsor: CHEPLAPHARM

APPLICATION
NDA022047
TYPE
NDA
ORIGINAL APPROVAL
2007-05-17
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

SEROQUEL XR · ReferencePrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XR · ReferencePrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XR · ReferencePrescription
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XR · ReferencePrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XR · ReferencePrescription
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-01-22Labeling · Supplement 48 · standard — Label ↗AP
2022-01-27Labeling · Supplement 46 · standard — Label ↗AP
2020-09-18Labeling · Supplement 41 · standard — Letter ↗AP
2020-09-18Labeling · Supplement 44 · standard — Letter ↗AP
2020-03-27Labeling · Supplement 42 · standard — Letter ↗AP
2020-02-05Labeling · Supplement 43 · 901 required — Letter ↗AP
2019-08-26Labeling · Supplement 40 · standard — Letter ↗AP
2018-11-29Labeling · Supplement 37 · standard — Label ↗AP
2018-11-29Labeling · Supplement 33 · standard — Label ↗AP
2017-02-23Labeling · Supplement 39 · 901 required — Label ↗AP
2016-06-17Labeling · Supplement 38 · 901 required — Letter ↗AP
2015-01-26Manufacturing (CMC) · Supplement 36 — Label ↗AP
2013-10-29Labeling · Supplement 34 · standard — Label ↗AP
2013-04-30Efficacy · Supplement 29 · standard — Label ↗AP
2013-04-30Labeling · Supplement 31 — Label ↗AP
2013-04-30Labeling · Supplement 26 — Letter ↗AP
2013-04-30Labeling · Supplement 30 — Letter ↗AP
2011-11-09REMS · Supplement 28 — Letter ↗AP
2011-07-08Labeling · Supplement 27 · unknown — Label ↗AP
2011-07-08Labeling · Supplement 23 · unknown — Label ↗AP
2011-05-17Labeling · Supplement 24 · unknown — Label ↗AP
2010-12-01Labeling · Supplement 25 · 901 required — Label ↗AP
2009-12-02Labeling · Supplement 19 — Letter ↗AP
2009-12-02Labeling · Supplement 17 — Label ↗AP
2009-12-02Efficacy · Supplement 11 · unknown — Label ↗AP
2009-12-02Labeling · Supplement 16 — Letter ↗AP
2009-12-02Labeling · Supplement 22 — Label ↗AP
2008-10-08Efficacy · Supplement 8 · unknown — Label ↗AP
2008-10-08Efficacy · Supplement 6 · unknown — Letter ↗AP
2008-10-08Efficacy · Supplement 7 · unknown — Label ↗AP
2008-08-14Labeling · Supplement 18 · standard — Letter ↗AP
2008-08-11Manufacturing (CMC) · Supplement 13 — Label ↗AP
2008-05-21Labeling · Supplement 9 · standard — Letter ↗AP
2008-03-13Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2007-05-17Type 3 - New Dosage Form · Original · unknown — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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