APPLICATION
ANDA206260
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-09
LATEST ACTION
2023-04-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-04-20Labeling · Supplement 10 · standardAP
2023-04-20Labeling · Supplement 7 · standardAP
2023-04-20Labeling · Supplement 8 · standardAP
2019-10-28Labeling · Supplement 4 · standardAP
2019-05-03Labeling · 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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