APPLICATION
NDA219407
TYPE
NDA
ORIGINAL APPROVAL
2025-08-21
LATEST ACTION
2025-08-21
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DAWNZERA (AUTOINJECTOR) · ReferencePrescription
DONIDALORSEN SODIUM EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) · SOLUTION · SUBCUTANEOUS
Approval history
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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