APPLICATION
ANDA204838
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-17
LATEST ACTION
2023-06-29
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
2023-06-29Labeling · Supplement 9 · standardAP
2023-06-29Labeling · Supplement 3 · standardAP
2023-06-29Labeling · Supplement 13 · standardAP
2023-06-29Labeling · Supplement 1 · standardAP
2023-06-29Labeling · Supplement 8 · standardAP
2023-06-29Labeling · Supplement 2 · standardAP
2016-06-17UNKNOWN · Original · standardAP
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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