Application 217388

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WAINUA (AUTOINJECTOR)EPLONTERSEN SODIUMSOLUTION;SUBCUTANEOUSEQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)YesYes
002WAINUAEPLONTERSEN SODIUMSOLUTION;SUBCUTANEOUSEQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85712SUPPL 2026-04-20
85697SUPPL 2026-04-16
84465SUPPL 2025-12-19
82104SUPPL 2025-05-01
82030SUPPL 2025-04-28
79745SUPPL 2024-09-26
79742SUPPL 2024-09-26
77197ORIG 2024-01-09
77109ORIG 2023-12-22
77100ORIG 2023-12-21