APPLICATION
ANDA077745
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-27
LATEST ACTION
2025-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 200MG 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 300MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET · ORAL
Approval history
2025-07-18Labeling · Supplement 25 · standardAP
2023-03-30Labeling · Supplement 23 · standardAP
2023-03-30Labeling · Supplement 16 · standardAP
2023-03-30Labeling · Supplement 19 · standardAP
2020-08-31Labeling · Supplement 13 · standardAP
2019-11-22Labeling · Supplement 11 · standardAP
2019-11-22Labeling · Supplement 12 · standardAP
2017-06-22Labeling · Supplement 10 · standardAP
2017-06-22Labeling · Supplement 9 · standardAP
2016-01-04Labeling · Supplement 5 · standardAP
2014-11-06Manufacturing (CMC) · Supplement 6AP
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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