APPLICATION
ANDA076904
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-29
LATEST ACTION
2023-09-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 1MG/ML · SOLUTION · ORAL
Approval history
2023-09-22Labeling · Supplement 9 · standardAP
2023-09-22Labeling · Supplement 16 · standardAP
2023-09-22Labeling · Supplement 14 · standardAP
2023-09-22Labeling · Supplement 10 · standardAP
2023-09-22Labeling · Supplement 13 · standardAP
2023-09-22Labeling · Supplement 11 · standardAP
2015-10-15Labeling · Supplement 7 · standardAP
2014-09-09Labeling · Supplement 5 · standardAP
2014-09-09Labeling · Supplement 6 · standardAP
2011-09-07Labeling · Supplement 4AP
2011-04-25Labeling · Supplement 3AP
2011-01-11Labeling · 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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