APPLICATION
ANDA204253
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-29
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-06-07Labeling · Supplement 21 · standardAP
2020-10-29Labeling · Supplement 12 · standardAP
2020-10-29Labeling · Supplement 11 · standardAP
2019-12-20Labeling · Supplement 10 · standardAP
2019-12-20Labeling · Supplement 6 · standardAP
2017-11-29UNKNOWN · 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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