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FDA ANDA · ANDA078269

RISPERIDONE

Sponsor: RISING

APPLICATION
ANDA078269
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-08
LATEST ACTION
2025-02-03
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

2025-02-03Labeling · Supplement 16 · standardAP
2025-02-03Labeling · Supplement 15 · standardAP
2020-01-21Labeling · Supplement 14 · standardAP
2020-01-21Labeling · Supplement 12 · standardAP
2020-01-21Labeling · Supplement 13 · standardAP
2014-09-25Labeling · Supplement 11 · standardAP
2012-10-22Labeling · Supplement 8 · standardAP
2012-02-10Labeling · Supplement 6AP
2012-02-10Labeling · Supplement 7AP
2011-04-22Labeling · Supplement 4AP
2010-12-29Labeling · Supplement 3AP
2009-12-08Labeling · Supplement 1AP
2008-10-08Original — 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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