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FDA ANDA · ANDA091388

QUETIAPINE FUMARATE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA091388
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-27
LATEST ACTION
2025-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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
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

Approval history

2025-07-08Labeling · Supplement 26 · standardAP
2023-05-11Labeling · Supplement 19 · standardAP
2023-05-11Labeling · Supplement 15 · standardAP
2023-05-11Labeling · Supplement 13 · standardAP
2023-05-11Labeling · Supplement 16 · standardAP
2023-05-11Labeling · Supplement 22 · standardAP
2023-05-11Labeling · Supplement 20 · standardAP
2017-09-26Labeling · Supplement 9 · standardAP
2017-09-26Labeling · Supplement 11 · standardAP
2015-08-21Labeling · Supplement 6 · standardAP
2013-08-28Labeling · Supplement 4 · standardAP
2012-03-27Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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