← FDA DRUG APPROVALS

FDA ANDA · ANDA215478

QUETIAPINE

Sponsor: UNICHEM

APPLICATION
ANDA215478
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-15
LATEST ACTION
2022-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 400MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 300MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-08-15UNKNOWN · Original · standardAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →