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FDA NDA · NDA209830

ARISTADA INITIO

aripiprazole lauroxil

Sponsor: ALKERMES INC

APPLICATION
NDA209830
TYPE
NDA
ORIGINAL APPROVAL
2018-06-29
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ARISTADA INITIO KIT · ReferencePrescription
ARIPIPRAZOLE LAUROXIL 675MG/2.4ML (281.25MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-01-22Labeling · Supplement 20 · standard — Label ↗AP
2021-03-30Labeling · Supplement 9 · standard — Letter ↗AP
2020-08-27Labeling · Supplement 5 · standard — Letter ↗AP
2018-06-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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