← FDA DRUG APPROVALS

FDA NDA · NDA022172

SEROQUEL XR

Sponsor: CHEPLAPHARM ARZNEIMITTEL GMBH

APPLICATION
NDA022172
TYPE
NDA
ORIGINAL APPROVAL
2007-11-15
LATEST ACTION
2007-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

SEROQUEL XRPrescription
QUETIAPINE FUMARATE 400MG · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XRPrescription
QUETIAPINE FUMARATE 200MG · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XRPrescription
QUETIAPINE FUMARATE 300MG · TABLET, EXTENDED RELEASE · ORAL
SEROQUEL XRPrescription
QUETIAPINE FUMARATE 50MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2007-11-15Type 6 - New Indication (no longer used) · Original · standard — Review ↗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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