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FDA NDA · NDA212154

VILTEPSO

viltolarsen

Sponsor: NIPPON SHINYAKU

APPLICATION
NDA212154
TYPE
NDA
ORIGINAL APPROVAL
2020-08-12
LATEST ACTION
2021-03-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VILTEPSO · ReferencePrescription
VILTOLARSEN 250MG/5ML (50MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-03-11Labeling · Supplement 2 · standard — Label ↗AP
2020-08-12Type 1 - New Molecular Entity · Original · priority — Label ↗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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