APPLICATION
ANDA201504
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-12
LATEST ACTION
2023-05-11
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
2023-05-11Labeling · Supplement 23 · standardAP
2023-05-11Labeling · Supplement 21 · standardAP
2023-05-11Labeling · Supplement 28 · standardAP
2023-05-11Labeling · Supplement 16 · standardAP
2023-05-11Labeling · Supplement 9 · standardAP
2023-05-11Labeling · Supplement 27 · standardAP
2023-05-11Labeling · Supplement 17 · standardAP
2015-10-06Labeling · Supplement 2 · standardAP
2013-08-29Labeling · Supplement 1 · standardAP
2013-02-12Not Applicable · 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.
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