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FDA NDA · NDA020272

RISPERDAL

risperidone

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020272
TYPE
NDA
ORIGINAL APPROVAL
1993-12-29
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

RISPERDAL · ReferencePrescription
RISPERIDONE 0.25MG · TABLET · ORAL
RISPERDAL · ReferencePrescription
RISPERIDONE 4MG · TABLET · ORAL
RISPERDAL · ReferencePrescription
RISPERIDONE 2MG · TABLET · ORAL
RISPERDAL · ReferencePrescription
RISPERIDONE 0.5MG · TABLET · ORAL
RISPERDALDiscontinued
RISPERIDONE 5MG · TABLET · ORAL
RISPERDAL · ReferencePrescription
RISPERIDONE 3MG · TABLET · ORAL
RISPERDAL · ReferencePrescription
RISPERIDONE 1MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 88 · standardLabelAP
2022-12-02Labeling · Supplement 87 · standardLabelAP
2021-02-12Labeling · Supplement 83 · standardLetterAP
2020-02-05Labeling · Supplement 85 · 901 requiredLetterAP
2019-01-25Labeling · Supplement 82 · standardLabelAP
2018-07-27Labeling · Supplement 80 · standardLetterAP
2017-02-23Labeling · Supplement 78 · 901 requiredLabelAP
2016-03-01Labeling · Supplement 77 · standardLetterAP
2016-02-09Manufacturing (CMC) · Supplement 76 · priorityAP
2014-04-28Labeling · Supplement 73 · standardLetterAP
2013-06-13Manufacturing (CMC) · Supplement 72 · priorityAP
2013-02-08Manufacturing (CMC) · Supplement 71 · priorityAP
2012-08-02Efficacy · Supplement 65 · standardLabelAP
2012-03-12Labeling · Supplement 67 · standardLetterAP
2011-09-24Labeling · Supplement 66 · standardLetterAP
2011-09-24Labeling · Supplement 60 · priorityLetterAP
2011-08-24Labeling · Supplement 59 · standardLabelAP
2011-06-15Labeling · Supplement 64 · standardLabelAP
2010-12-01Labeling · Supplement 63 · 901 requiredLabelAP
2010-08-30Labeling · Supplement 55 · standardLabelAP
2010-08-30Labeling · Supplement 61 · unknownLetterAP
2010-08-30Labeling · Supplement 58 · unknownLabelAP
2010-08-30Labeling · Supplement 62 · unknownLetterAP
2009-07-19Labeling · Supplement 56 · 901 requiredLabelAP
2008-08-14Labeling · Supplement 54 · standardLetterAP
2007-08-22Efficacy · Supplement 47 · priorityLabelAP
2007-08-22Efficacy · Supplement 46 · priorityReviewAP
2006-10-06Efficacy · Supplement 36 · priorityReviewAP
2006-10-06Efficacy · Supplement 41 · priorityReviewAP
2005-08-17Labeling · Supplement 42 · standardLabelAP
2003-12-04Efficacy · Supplement 26 · standardLabelAP
2003-12-04Efficacy · Supplement 27 · standardReviewAP
2003-11-21Labeling · Supplement 35 · standardLetterAP
2003-10-29Labeling · Supplement 25 · standardLetterAP
2003-09-10Labeling · Supplement 33 · standardReviewAP
2002-11-19Labeling · Supplement 24 · standardLetterAP
2002-07-09Manufacturing (CMC) · Supplement 23 · priorityAP
2002-03-03Efficacy · Supplement 8 · standardReviewAP
2001-10-22Manufacturing (CMC) · Supplement 20 · priorityAP
2001-09-28Manufacturing (CMC) · Supplement 21 · priorityAP
VIEW ON DRUGS@FDA ↗

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