APPLICATION
ANDA203906
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-14
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 17 · standardAP
2025-01-13Labeling · Supplement 15 · standardAP
2022-05-27Labeling · Supplement 9 · standardAP
2020-02-06Labeling · Supplement 8 · standardAP
2019-12-10Labeling · Supplement 7 · standardAP
2017-02-23Labeling · Supplement 4 · standardAP
2017-02-01Labeling · Supplement 1 · standardAP
2016-08-18Labeling · Supplement 3 · standardAP
2015-08-14UNKNOWN · 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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