APPLICATION
ANDA203802
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-24
LATEST ACTION
2020-05-29
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
2020-05-29Labeling · Supplement 9 · standardAP
2020-05-29Labeling · Supplement 5 · standardAP
2020-05-29Labeling · Supplement 6 · standardAP
2020-05-29Labeling · Supplement 13 · standardAP
2020-05-29Labeling · Supplement 11 · standardAP
2015-09-24UNKNOWN · 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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