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FDA ANDA · ANDA077953

RISPERIDONE

Sponsor: APOTEX INC

APPLICATION
ANDA077953
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-15
LATEST ACTION
2025-09-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.25MG · TABLET · ORAL

Approval history

2025-09-11Labeling · Supplement 17 · standardAP
2020-08-28Labeling · Supplement 14 · standardAP
2020-08-28Labeling · Supplement 12 · standardAP
2020-08-28Labeling · Supplement 10 · standardAP
2020-08-28Labeling · Supplement 13 · standardAP
2020-08-28Labeling · Supplement 11 · standardAP
2014-09-23Labeling · Supplement 9 · standardAP
2013-07-18Labeling · Supplement 6AP
2012-01-05Labeling · Supplement 7AP
2011-05-27Labeling · Supplement 4AP
2010-04-27Labeling · Supplement 3AP
2008-09-15Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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