SEROQUEL XR (QUETIAPINE)
Summary
FDA approved SEROQUEL XR (QUETIAPINE) by CHEPLAPHARM. NDA (New Drug) approval (Labeling) on 2025-01-22. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA022047-48
Action Date
2025-01-22
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
SEROQUEL XR (generic: QUETIAPINE), TABLET, EXTENDED RELEASE, ORAL. Application: NDA022047
Company
Context & Analysis
CHEPLAPHARM has 6 FDA actions in our database.
Frequently Asked Questions
How often does CHEPLAPHARM have FDA actions?
CHEPLAPHARM has 6 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA022047-48" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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