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FDA ANDA · ANDA090681

QUETIAPINE FUMARATE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA090681
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-01
LATEST ACTION
2023-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-09-19Labeling · Supplement 13 · standardAP
2023-04-19Labeling · Supplement 8 · standardAP
2023-04-19Labeling · Supplement 11 · standardAP
2023-04-19Labeling · Supplement 7 · standardAP
2023-04-19Labeling · Supplement 5 · standardAP
2023-04-19Labeling · Supplement 12 · standardAP
2017-05-09Original — Letter ↗AP
2016-11-01Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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