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FDA ANDA · ANDA207240
ARIPIPRAZOLE
aripiprazole orally disintegrating
Sponsor: SCIEGEN PHARMS
APPLICATION
ANDA207240
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-18
LATEST ACTION
2025-01-24
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-01-24Labeling · Supplement 16 · standardAP
2025-01-23Labeling · Supplement 14 · standardAP
2025-01-23Labeling · Supplement 11 · standardAP
2021-02-01Labeling · Supplement 6 · standardAP
2020-02-05Labeling · Supplement 5 · standardAP
2018-04-18UNKNOWN · 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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