Application 219407

Type
NDA
Sponsor
IONIS PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAWNZERA (AUTOINJECTOR)DONIDALORSEN SODIUMSOLUTION;SUBCUTANEOUSEQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83629ORIG 2025-10-02
83207ORIG 2025-08-27
83170ORIG 2025-08-22