Application 215842

Type
NDA
Sponsor
NOVO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVFLOZANEDOSIRAN SODIUMSOLUTION;INJECTIONEQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)YesYes
002RIVFLOZANEDOSIRAN SODIUMSOLUTION;INJECTIONEQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)YesYes
003RIVFLOZANEDOSIRAN SODIUMSOLUTION;INJECTIONEQ 160MG BASE/ML (EQ 160MG BASE/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81775SUPPL 2025-03-28
81772SUPPL 2025-03-27
75841ORIG 2023-10-19
75651ORIG 2023-10-03
75631ORIG 2023-09-29