FDA-2024-0061-V061
Major variation for application FDA-2024-0061. Major variation: Analytical Method Change for Kcluximab — critical change
Variation Number
FDA-2024-0061-V061
Type
Major
Application
Change
Status
Approved
Fee
€57,886
Submitted
2022-12-11
Approved
2024-04-27
Description
Major variation: Analytical Method Change for Kcluximab — critical change