Application 216718

Type
NDA
Sponsor
BIOGEN US

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SKYCLARYSOMAVELOXOLONECAPSULE;ORAL50MGYesYes

Documents

DocumentSubmission typeDate
85668SUPPL 2026-04-10
85657SUPPL 2026-04-09
80720SUPPL 2024-12-26
80719SUPPL 2024-12-26
80696SUPPL 2024-12-23
80695SUPPL 2024-12-23
77319SUPPL 2024-01-26
77315SUPPL 2024-01-26
77314SUPPL 2024-01-26
73907ORIG 2023-03-30
73643ORIG 2023-03-01
73632ORIG 2023-02-28