APPLICATION
ANDA078516
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-01
LATEST ACTION
2019-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2019-11-26Labeling · Supplement 12 · standardAP
2019-11-26Labeling · Supplement 10 · standardAP
2019-11-26Labeling · Supplement 9 · standardAP
2019-11-26Labeling · Supplement 13 · standardAP
2014-11-02Labeling · Supplement 8 · standardAP
2013-04-16Labeling · Supplement 7 · standardAP
2012-07-25Labeling · Supplement 5AP
2012-04-30Labeling · Supplement 6AP
2011-07-11Labeling · Supplement 4AP
2011-06-10Labeling · Supplement 3AP
2010-12-29Labeling · Supplement 2AP
2009-11-06Manufacturing (CMC) · Supplement 1AP
2009-05-01OriginalAP
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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