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FDA ANDA · ANDA078828

RISPERIDONE

Sponsor: JUBILANT CADISTA

APPLICATION
ANDA078828
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-23
LATEST ACTION
2011-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2011-06-30Labeling · Supplement 2AP
2011-03-16Labeling · Supplement 1AP
2009-03-23Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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