APPLICATION
ANDA204707
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-23
LATEST ACTION
2025-09-03
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
2025-09-03Labeling · Supplement 20 · standardAP
2024-03-21Labeling · Supplement 16 · standardAP
2024-03-21Labeling · Supplement 9 · standardAP
2019-09-23UNKNOWN · OriginalAP
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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