← FDA DRUG APPROVALS

FDA NDA · NDA020639

SEROQUEL

quetiapine

Sponsor: CHEPLAPHARM

APPLICATION
NDA020639
TYPE
NDA
ORIGINAL APPROVAL
1997-09-26
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

SEROQUEL · ReferencePrescription
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET · ORAL
SEROQUEL · ReferencePrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET · ORAL
SEROQUEL · ReferencePrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET · ORAL
SEROQUEL · ReferencePrescription
QUETIAPINE FUMARATE EQ 25MG BASE · TABLET · ORAL
SEROQUEL · ReferencePrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET · ORAL
SEROQUEL · ReferenceDiscontinued
QUETIAPINE FUMARATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SEROQUEL · ReferencePrescription
QUETIAPINE FUMARATE EQ 100MG BASE · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 74 · standard — Label ↗AP
2022-01-27Labeling · Supplement 72 · standard — Letter ↗AP
2020-09-18Labeling · Supplement 70 · standard — Letter ↗AP
2020-03-27Labeling · Supplement 68 · standard — Letter ↗AP
2020-02-05Labeling · Supplement 69 · 901 required — Letter ↗AP
2019-08-26Labeling · Supplement 66 · standard — Letter ↗AP
2018-11-29Labeling · Supplement 60 · standard — Label ↗AP
2018-11-29Labeling · Supplement 63 · standard — Label ↗AP
2017-02-23Labeling · Supplement 65 · 901 required — Label ↗AP
2016-06-17Labeling · Supplement 64 · 901 required — Label ↗AP
2013-10-29Labeling · Supplement 61 · standard — Label ↗AP
2013-04-30Labeling · Supplement 59 · standard — Letter ↗AP
2013-04-30Efficacy · Supplement 57 · standard — Label ↗AP
2013-04-30Labeling · Supplement 53 · standard — Label ↗AP
2013-04-30Labeling · Supplement 58 · standard — Label ↗AP
2011-11-09REMS · Supplement 55 — Letter ↗AP
2011-07-08Labeling · Supplement 54 · unknown — Review ↗AP
2011-07-08Labeling · Supplement 49 · unknown — Review ↗AP
2011-05-17Labeling · Supplement 51 · unknown — Letter ↗AP
2010-12-01Labeling · Supplement 52 · 901 required — Label ↗AP
2009-12-02Efficacy · Supplement 46 · priority — Label ↗AP
2009-12-02Efficacy · Supplement 45 · priority — Pediatric Statistical Review ↗AP
2008-10-24Labeling · Supplement 30 · standard — Letter ↗AP
2008-08-14Labeling · Supplement 43 · standard — Letter ↗AP
2008-05-13Labeling · Supplement 38 · standard — Letter ↗AP
2008-05-13Labeling · Supplement 40 · standard — Letter ↗AP
2008-05-13Efficacy · Supplement 37 · standard — Review ↗AP
2008-05-13Labeling · Supplement 25 · standard — Letter ↗AP
2008-01-28Labeling · Supplement 39 · standard — Letter ↗AP
2008-01-28Labeling · Supplement 31 · standard — Letter ↗AP
2007-07-30Labeling · Supplement 35 · standard — Letter ↗AP
2006-10-20Efficacy · Supplement 26 · unknown — Label ↗AP
2006-09-20Labeling · Supplement 23 · standard — Label ↗AP
2006-02-07Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2004-07-21Labeling · Supplement 20 · standard — Letter ↗AP
2004-01-12Efficacy · Supplement 16 · standard — Review ↗AP
2004-01-12Efficacy · Supplement 17 · standard — Review ↗AP
2002-12-06Manufacturing (CMC) · Supplement 15 · standardAP
2001-11-16Manufacturing (CMC) · Supplement 13 · standardAP
2001-03-27Labeling · Supplement 11 · standard — Letter ↗AP
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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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