APPLICATION
ANDA077719
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-29
LATEST ACTION
2022-12-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 1MG/ML · SOLUTION · ORAL
Approval history
2022-12-27Labeling · Supplement 13 · standardAP
2022-12-27Labeling · Supplement 11 · standardAP
2022-12-27Labeling · Supplement 9 · standardAP
2022-12-27Labeling · Supplement 14 · standardAP
2022-12-27Labeling · Supplement 12 · standardAP
2016-01-06Labeling · Supplement 7 · standardAP
2013-06-27Labeling · Supplement 4 · standardAP
2012-10-25Labeling · Supplement 3 · standardAP
2012-01-30Labeling · Supplement 2AP
2009-07-29OriginalAP
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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