APPLICATION
ANDA205618
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-06
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PALIPERIDONEPrescription
PALIPERIDONE 9MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEPrescription
PALIPERIDONE 3MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEPrescription
PALIPERIDONE 6MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEPrescription
PALIPERIDONE 1.5mg · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-04-23Labeling · Supplement 13 · standardAP
2023-09-21Labeling · Supplement 6 · standardAP
2020-10-30Labeling · Supplement 4 · standardAP
2020-10-30Labeling · Supplement 2 · standardAP
2018-04-06UNKNOWN · 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.
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