APPLICATION
ANDA210479
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-29
LATEST ACTION
2025-01-24
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 1MG/ML · SOLUTION · ORAL
Approval history
2025-01-24Labeling · Supplement 13 · standardAP
2024-11-12Labeling · Supplement 8 · standardAP
2024-11-12Labeling · Supplement 12 · standardAP
2024-11-12Labeling · Supplement 9 · standardAP
2024-11-12Labeling · Supplement 5 · standardAP
2020-02-05Labeling · Supplement 4 · standardAP
2020-02-04Labeling · Supplement 2 · standardAP
2019-01-29UNKNOWN · 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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