APPLICATION
ANDA078708
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-28
LATEST ACTION
2025-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 15MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 20MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 30MG · TABLET · ORAL
Approval history
2025-11-14Labeling · Supplement 9 · standardAP
2025-11-14Labeling · Supplement 3 · standardAP
2025-11-14Labeling · Supplement 8 · standardAP
2025-11-14Labeling · Supplement 6 · standardAP
2025-11-14Labeling · Supplement 4 · standardAP
2025-11-14Labeling · Supplement 2 · standardAP
2015-04-28OriginalAP
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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