APPLICATION
ANDA206174
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-12
LATEST ACTION
2023-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 30MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 15MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 5MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 20MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 10MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 2MG · TABLET · ORAL
Approval history
2023-06-15Labeling · Supplement 34 · standardAP
2023-06-15Labeling · Supplement 12 · standardAP
2023-06-15Labeling · Supplement 10 · standardAP
2023-06-15Labeling · Supplement 2 · standardAP
2017-08-04Manufacturing (CMC) · Supplement 3AP
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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