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FDA NDA · NDA215842

RIVFLOZA

nedosiran

Sponsor: NOVO

APPLICATION
NDA215842
TYPE
NDA
ORIGINAL APPROVAL
2023-09-29
LATEST ACTION
2025-03-27
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RIVFLOZA · ReferencePrescription
NEDOSIRAN SODIUM EQ 160MG BASE/ML (EQ 160MG BASE/ML) · SOLUTION · INJECTION
RIVFLOZA · ReferencePrescription
NEDOSIRAN SODIUM EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) · SOLUTION · INJECTION
RIVFLOZA · ReferencePrescription
NEDOSIRAN SODIUM EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) · SOLUTION · INJECTION

Approval history

2025-03-27Efficacy · Supplement 2 · standard — Label ↗AP
2023-09-29Type 1 - New Molecular Entity · Original · standard — 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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