APPLICATION
ANDA079158
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-03
LATEST ACTION
2015-11-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 1MG/ML · SOLUTION · ORAL
Approval history
2015-11-12Labeling · Supplement 10 · standardAP
2012-10-22Labeling · Supplement 9 · standardAP
2012-01-30Labeling · Supplement 5AP
2011-11-04Labeling · Supplement 3AP
2011-10-26Labeling · Supplement 2AP
2011-04-20Labeling · Supplement 1AP
2010-12-03OriginalAP
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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