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FDA ANDA · ANDA078707

RISPERIDONE

Sponsor: RENATA

APPLICATION
ANDA078707
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-29
LATEST ACTION
2025-05-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-05-16Labeling · Supplement 15 · standardAP
2025-05-16Labeling · Supplement 16 · standardAP
2025-05-16Labeling · Supplement 22 · standardAP
2025-05-16Labeling · Supplement 20 · standardAP
2014-09-25Labeling · Supplement 12 · standardAP
2012-10-18Labeling · Supplement 9 · standardAP
2012-03-01Labeling · Supplement 6AP
2011-11-15Labeling · Supplement 5AP
2011-08-25Labeling · Supplement 4AP
2011-06-30Labeling · Supplement 3AP
2011-04-08Labeling · Supplement 2AP
2010-02-19Labeling · Supplement 1AP
2008-12-29Original — 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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