01 1Isotopia Molecular Imaging
01 1LUTETIUM CHLORIDE CARRIER ADDED (LU 177 C.A.) SOLUTION
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-12
Pay. Date : 2023-07-20
DMF Number : 38563
Submission : 2023-07-24
Status : Active
Type : II
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Isotopia Molecular Imaging Ltd, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is LUTETIUM CHLORIDE CARRIER ADDED (LU 177 C.A.) SOLUTION, with a corresponding US DMF Number 38563.
Remarkably, this DMF maintains an Active status since its submission on July 24, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 12, 2023, and payment made on July 20, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
