← FDA DRUG APPROVALS

FDA NDA · NDA021999

INVEGA

paliperidone

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021999
TYPE
NDA
ORIGINAL APPROVAL
2006-12-19
LATEST ACTION
2025-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription

Products

INVEGA · ReferenceDiscontinued
PALIPERIDONE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
INVEGA · ReferencePrescription
PALIPERIDONE 6MG · TABLET, EXTENDED RELEASE · ORAL
INVEGA · ReferencePrescription
PALIPERIDONE 9MG · TABLET, EXTENDED RELEASE · ORAL
INVEGA · ReferencePrescription
PALIPERIDONE 3MG · TABLET, EXTENDED RELEASE · ORAL
INVEGA · ReferenceDiscontinued
PALIPERIDONE 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-01-23Labeling · Supplement 41 · standard — Label ↗AP
2025-01-23Labeling · Supplement 40 · standard — Label ↗AP
2022-03-24Manufacturing (CMC) · Supplement 39 · standard — Label ↗AP
2021-02-12Labeling · Supplement 37 · standard — Letter ↗AP
2019-01-25Labeling · Supplement 36 · standard — Label ↗AP
2018-07-27Labeling · Supplement 35 · standard — Letter ↗AP
2017-08-11Labeling · Supplement 34 · standard — Label ↗AP
2017-02-23Labeling · Supplement 32 · 901 required — Label ↗AP
2016-03-01Labeling · Supplement 30 · standard — Label ↗AP
2014-04-29Labeling · Supplement 29 · standard — Label ↗AP
2013-06-17Manufacturing (CMC) · Supplement 28 · standardAP
2011-04-06Efficacy · Supplement 24 · priority — Letter ↗AP
2011-04-06Labeling · Supplement 20 · standard — Label ↗AP
2011-02-16Labeling · Supplement 17 · unknown — Letter ↗AP
2010-12-01Labeling · Supplement 23 · 901 required — Label ↗AP
2010-03-03Labeling · Supplement 18 · unknown — Label ↗AP
2009-12-22Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2009-10-30Labeling · Supplement 11 · standard — Label ↗AP
2009-07-31Efficacy · Supplement 13 · priority — Letter ↗AP
2009-07-31Efficacy · Supplement 14 · priority — Letter ↗AP
2009-07-19Labeling · Supplement 15 · 901 required — Letter ↗AP
2008-09-04Labeling · Supplement 6 · standard — Label ↗AP
2008-08-26Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
2008-08-26Manufacturing (CMC) · Supplement 5 — Label ↗AP
2008-08-14Labeling · Supplement 10 · standard — Label ↗AP
2008-05-16Labeling · Supplement 7 · standard — Letter ↗AP
2007-12-21Efficacy · Supplement 1 · unknown — Label ↗AP
2007-12-21Labeling · Supplement 2 · standard — Letter ↗AP
2007-04-27Labeling · Supplement 3 · standardAP
2006-12-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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