Advanced Accelerator Applications USA, Inc.
3 FDA actions
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac
Advanced Accelerator Applications USA, Inc.
drugClass II
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacture
Advanced Accelerator Applications USA, Inc.
drugClass III
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l
Advanced Accelerator Applications USA, Inc.
drugClass III