← FDA DRUG APPROVALS

FDA NDA · NDA216655

OPIPZA

aripiprazole

Sponsor: XIAMEN LP PHARM CO

APPLICATION
NDA216655
TYPE
NDA
ORIGINAL APPROVAL
2024-07-22
LATEST ACTION
2025-03-20
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription

Products

OPIPZA · ReferencePrescription
ARIPIPRAZOLE 10MG · FILM · ORAL
OPIPZA · ReferencePrescription
ARIPIPRAZOLE 2MG · FILM · ORAL
OPIPZA · ReferencePrescription
ARIPIPRAZOLE 5MG · FILM · ORAL

Approval history

2025-03-20Labeling · Supplement 1 · standard — Letter ↗AP
2024-07-22Type 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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