APPLICATION
ANDA218514
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-26
LATEST ACTION
2025-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PALIPERIDONEPrescription
PALIPERIDONE 6MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEPrescription
PALIPERIDONE 1.5MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEPrescription
PALIPERIDONE 9MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEPrescription
PALIPERIDONE 3MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-03-27Labeling · Supplement 2 · standardAP
2024-06-26UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.