APPLICATION
ANDA202645
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-03
LATEST ACTION
2026-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PALIPERIDONEDiscontinued
PALIPERIDONE 6MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEDiscontinued
PALIPERIDONE 1.5MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEDiscontinued
PALIPERIDONE 9MG · TABLET, EXTENDED RELEASE · ORAL
PALIPERIDONEDiscontinued
PALIPERIDONE 3MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-04-02Labeling · Supplement 17 · standardAP
2021-11-16Labeling · Supplement 13 · standardAP
2020-05-29Labeling · Supplement 8 · standardAP
2020-05-29Labeling · Supplement 6 · standardAP
2020-05-29Labeling · Supplement 7 · standardAP
2020-05-29Labeling · Supplement 5 · 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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