Application 219019

Type
NDA
Sponsor
GENZYME CORP

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001QFITLIAFITUSIRAN SODIUMSOLUTION;SUBCUTANEOUSEQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML)YesYes
002QFITLIAFITUSIRAN SODIUMSOLUTION;SUBCUTANEOUSEQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML)YesYes

Documents

DocumentSubmission typeDate
81819ORIG 2026-03-02
82174ORIG 2025-05-14
81899ORIG 2025-04-09
81818ORIG 2025-04-03