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FDA ANDA · ANDA200363

QUETIAPINE FUMARATE

Sponsor: TORRENT PHARMS LTD

APPLICATION
ANDA200363
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-27
LATEST ACTION
2015-11-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 100MG BASE · TABLET · ORAL
QUETIAPINE FUMARATEDiscontinued
QUETIAPINE FUMARATE EQ 25MG 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 50MG BASE · TABLET · ORAL

Approval history

2015-11-24Labeling · Supplement 3 · standardAP
2012-03-27Not Applicable · OriginalLetterAP
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