APPLICATION
ANDA090749
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-27
LATEST ACTION
2025-09-12
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 50MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 100MG BASE · TABLET · ORAL
Approval history
2025-09-12Labeling · Supplement 17 · standardAP
2023-02-08Labeling · Supplement 12 · standardAP
2023-02-08Labeling · Supplement 10 · standardAP
2023-02-08Labeling · Supplement 15 · standardAP
2023-02-08Labeling · Supplement 11 · standardAP
2019-12-11Labeling · Supplement 8 · standardAP
2019-12-11Labeling · Supplement 7 · standardAP
2017-06-22Labeling · Supplement 5 · standardAP
2017-06-22Labeling · Supplement 6 · standardAP
2015-09-04Labeling · Supplement 4 · standardAP
2015-09-04Labeling · 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.
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