APPLICATION
ANDA201519
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-28
LATEST ACTION
2019-04-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 5MG · TABLET · ORAL
Approval history
2019-04-05Labeling · Supplement 35 · standardAP
2019-04-05Labeling · Supplement 33 · standardAP
2019-04-05Labeling · Supplement 36 · standardAP
2016-10-18Labeling · Supplement 29 · standardAP
2016-10-18Labeling · Supplement 27 · standardAP
2016-10-18Labeling · Supplement 31 · standardAP
2015-04-28UNKNOWN · 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.
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