APPLICATION
ANDA078679
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2022-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 25MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 100MG BASE · TABLET · ORAL
Approval history
2022-06-17Labeling · Supplement 17 · standardAP
2022-06-17Labeling · Supplement 15 · standardAP
2022-06-17Labeling · Supplement 13 · standardAP
2022-06-17Labeling · Supplement 16 · standardAP
2022-06-17Labeling · Supplement 14 · standardAP
2022-06-17Labeling · Supplement 9 · standardAP
2022-06-17Labeling · Supplement 10 · standardAP
2015-11-05Labeling · Supplement 8 · standardAP
2015-11-05Labeling · Supplement 7 · standardAP
2012-12-14OriginalAP
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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