← FDA DRUG APPROVALS

FDA NDA · NDA021346

RISPERDAL CONSTA

risperidone

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021346
TYPE
NDA
ORIGINAL APPROVAL
2003-10-29
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

RISPERDAL CONSTA · ReferencePrescription
RISPERIDONE 37.5MG/VIAL · POWDER · INTRAMUSCULAR
RISPERDAL CONSTA · ReferencePrescription
RISPERIDONE 50MG/VIAL · POWDER · INTRAMUSCULAR
RISPERDAL CONSTA · ReferencePrescription
RISPERIDONE 25MG/VIAL · POWDER · INTRAMUSCULAR
RISPERDAL CONSTA · ReferencePrescription
RISPERIDONE 12.5MG/VIAL · POWDER · INTRAMUSCULAR

Approval history

2025-01-22Labeling · Supplement 65 · standard — Label ↗AP
2021-02-12Labeling · Supplement 61 · standard — Letter ↗AP
2021-01-07Labeling · Supplement 64 · standard — Letter ↗AP
2020-02-05Labeling · Supplement 63 · 901 required — Letter ↗AP
2019-11-22Labeling · Supplement 62 · standard — Review ↗AP
2019-01-25Labeling · Supplement 60 · standard — Label ↗AP
2018-07-27Labeling · Supplement 58 · standard — Letter ↗AP
2018-04-12Labeling · Supplement 59 · standard — Review ↗AP
2017-02-23Labeling · Supplement 56 · 901 required — Label ↗AP
2016-11-18Labeling · Supplement 54 · standard — Review ↗AP
2016-03-01Labeling · Supplement 55 · standard — Review ↗AP
2014-06-05Manufacturing (CMC) · Supplement 52 — Review ↗AP
2014-04-28Labeling · Supplement 51 · standard — Review ↗AP
2013-10-22Manufacturing (CMC) · Supplement 50 — Review ↗AP
2013-10-10Manufacturing (CMC) · Supplement 47AP
2013-07-18Manufacturing (CMC) · Supplement 49 — Review ↗AP
2013-02-26Manufacturing (CMC) · Supplement 48 — Review ↗AP
2012-03-12Labeling · Supplement 44 · standard — Letter ↗AP
2011-12-07Labeling · Supplement 32 · standard — Letter ↗AP
2011-12-07Labeling · Supplement 41 · standard — Label ↗AP
2011-09-24Labeling · Supplement 37 — Letter ↗AP
2011-09-24Labeling · Supplement 43 · standard — Letter ↗AP
2011-08-24Labeling · Supplement 36 · standard — Letter ↗AP
2011-06-15Labeling · Supplement 42 · standard — Letter ↗AP
2010-12-01Labeling · Supplement 40 · 901 required — Letter ↗AP
2010-08-30Labeling · Supplement 38 · unknown — Letter ↗AP
2010-08-30Labeling · Supplement 39 · unknown — Label ↗AP
2010-08-30Labeling · Supplement 35 · unknown — Letter ↗AP
2010-08-30Labeling · Supplement 31 · standard — Label ↗AP
2009-07-19Labeling · Supplement 33 · 901 required — Letter ↗AP
2009-05-15Efficacy · Supplement 28 · unknown — Label ↗AP
2009-05-15Efficacy · Supplement 25 · unknown — Label ↗AP
2008-10-08Labeling · Supplement 23 · standard — Label ↗AP
2008-10-08Labeling · Supplement 21 · standard — Label ↗AP
2008-10-08Labeling · Supplement 26 · standard — Label ↗AP
2008-10-08Labeling · Supplement 22 · standard — Label ↗AP
2008-08-14Labeling · Supplement 27 · standard — Letter ↗AP
2007-04-12Efficacy · Supplement 15 · unknown — Label ↗AP
2007-03-09Labeling · Supplement 20 · standard — Letter ↗AP
2006-10-20Labeling · Supplement 9 · standard — Letter ↗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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