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FDA NDA · NDA218466

VIJOICE

alpelisib

Sponsor: NOVARTIS

APPLICATION
NDA218466
TYPE
NDA
ORIGINAL APPROVAL
2024-04-24
LATEST ACTION
2025-07-22
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

VIJOICE · ReferencePrescription
ALPELISIB 50MG/PACKET · GRANULE · ORAL

Approval history

2025-07-22Labeling · Supplement 1 · standardLetterAP
2024-04-24Type 3 - New Dosage Form · Original · standardLetterAP
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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