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FDA NDA · NDA217006

ABILIFY ASIMTUFII

aripiprazole

Sponsor: OTSUKA

APPLICATION
NDA217006
TYPE
NDA
ORIGINAL APPROVAL
2023-04-27
LATEST ACTION
2025-03-28
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ABILIFY ASIMTUFII · ReferencePrescription
ARIPIPRAZOLE 960MG/3.2ML (300MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ABILIFY ASIMTUFII · ReferencePrescription
ARIPIPRAZOLE 720MG/2.4ML (300MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-03-28Efficacy · Supplement 1 · standard — Letter ↗AP
2025-01-22Labeling · Supplement 2 · standard — Label ↗AP
2023-04-27Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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