Application 217369

Type
NDA
Sponsor
BIOGEN INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZURZUVAEZURANOLONECAPSULE;ORAL20MGYesNo
002ZURZUVAEZURANOLONECAPSULE;ORAL25MGYesNo
003ZURZUVAEZURANOLONECAPSULE;ORAL30MGYesYes

Documents

DocumentSubmission typeDate
85739SUPPL 2026-04-24
85730SUPPL 2026-04-21
79286SUPPL 2024-08-02
79285SUPPL 2024-08-02
79276SUPPL 2024-08-02
76645ORIG 2023-10-31
75323ORIG 2023-08-31
75010ORIG 2023-08-08
75012ORIG 2023-08-07