APPLICATION
ANDA204111
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-07
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 5MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 20MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 10MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 2MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 30MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 15MG · TABLET · ORAL
Approval history
2023-06-07Labeling · Supplement 17 · standardAP
2016-10-07UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.