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FDA NDA · NDA021444

RISPERDAL M-TAB

risperidone

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021444
TYPE
NDA
ORIGINAL APPROVAL
2003-04-02
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

RISPERDAL · ReferenceDiscontinued
RISPERIDONE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERDAL · ReferenceDiscontinued
RISPERIDONE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERDAL · ReferenceDiscontinued
RISPERIDONE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERDAL · ReferenceDiscontinued
RISPERIDONE 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERDAL · ReferenceDiscontinued
RISPERIDONE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2025-01-22Labeling · Supplement 60 · standard — Label ↗AP
2022-12-02Labeling · Supplement 59 · standard — Label ↗AP
2021-02-12Labeling · Supplement 57 · standard — Letter ↗AP
2020-02-05Labeling · Supplement 58 · 901 required — Letter ↗AP
2019-01-25Labeling · Supplement 56 · standard — Label ↗AP
2018-07-27Labeling · Supplement 54 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 52 · 901 required — Label ↗AP
2016-03-01Labeling · Supplement 51 · standard — Letter ↗AP
2014-04-28Labeling · Supplement 48 · standard — Label ↗AP
2012-08-02Efficacy · Supplement 41 · standard — Letter ↗AP
2012-03-12Labeling · Supplement 43 · standard — Letter ↗AP
2011-09-24Labeling · Supplement 35 · standard — Label ↗AP
2011-09-24Labeling · Supplement 42 · standard — Letter ↗AP
2011-08-24Labeling · Supplement 34 · standard — Label ↗AP
2011-06-15Labeling · Supplement 40 · standard — Letter ↗AP
2010-12-01Labeling · Supplement 39 · 901 required — Label ↗AP
2010-08-30Labeling · Supplement 37 · unknown — Label ↗AP
2010-08-30Labeling · Supplement 33 · unknown — Letter ↗AP
2010-08-30Labeling · Supplement 36 · unknown — Letter ↗AP
2010-08-30Labeling · Supplement 30 · standard — Letter ↗AP
2009-07-19Labeling · Supplement 31 · 901 required — Letter ↗AP
2008-08-14Labeling · Supplement 29 · standard — Letter ↗AP
2007-08-22Efficacy · Supplement 20 · priority — Label ↗AP
2007-08-22Efficacy · Supplement 21 · priority — Review ↗AP
2006-10-06Efficacy · Supplement 8 · priority — Review ↗AP
2006-10-06Efficacy · Supplement 15 · standard — Letter ↗AP
2005-08-17Labeling · Supplement 16 · standard — Letter ↗AP
2004-12-23Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2003-12-04Efficacy · Supplement 2 · standard — Label ↗AP
2003-12-04Efficacy · Supplement 3 · standard — Label ↗AP
2003-11-21Labeling · Supplement 7 · standard — Letter ↗AP
2003-10-29Labeling · Supplement 5 · standard — Letter ↗AP
2003-09-10Labeling · Supplement 4 · standard — Review ↗AP
2003-04-02Type 3 - New Dosage Form · Original · standard — Review ↗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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