APPLICATION
ANDA202674
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-08
LATEST ACTION
2023-05-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 100MG BASE · TABLET · ORAL
Approval history
2023-05-30Labeling · Supplement 22 · standardAP
2021-11-02Labeling · Supplement 16 · standardAP
2021-11-02Labeling · Supplement 12 · standardAP
2021-11-02Labeling · Supplement 9 · standardAP
2021-11-02Labeling · Supplement 13 · standardAP
2021-11-02Labeling · Supplement 11 · standardAP
2017-07-03Manufacturing (CMC) · Supplement 5 · unknownAP
2017-06-28Labeling · Supplement 1 · standardAP
2017-06-28Labeling · Supplement 4 · standardAP
2016-03-08UNKNOWN · OriginalAP
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.