FDA-2024-0081-V481
Type II variation for application FDA-2024-0081. Type II variation: Analytical Method Change for Kcluximab — critical change
Variation Number
FDA-2024-0081-V481
Type
Type II
Application
Change
Status
Blocked
Fee
€15,299
Submitted
2022-11-25
Approved
—
Description
Type II variation: Analytical Method Change for Kcluximab — critical change