APPLICATION
ANDA202152
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-27
LATEST ACTION
2026-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 100MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 25MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET · ORAL
Approval history
2026-01-07Labeling · Supplement 23 · standardAP
2023-06-05Labeling · Supplement 21 · standardAP
2023-06-05Labeling · Supplement 20 · standardAP
2023-06-05Labeling · Supplement 19 · standardAP
2023-06-05Labeling · Supplement 17 · standardAP
2019-11-22Labeling · Supplement 15 · standardAP
2019-11-22Labeling · Supplement 16 · standardAP
2017-06-30Labeling · Supplement 10 · standardAP
2017-06-30Labeling · Supplement 9 · standardAP
2014-10-30Labeling · Supplement 1 · standardAP
2014-10-26Labeling · Supplement 2 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.