01 1IRE Elit
01 1SODIUM [1311] IODIDE (LEU FISSION)
01 1Belgium
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-13
Pay. Date : 2025-05-08
DMF Number : 36442
Submission : 2022-01-21
Status : Active
Type : II
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Institut National Des Radioelements, based in Belgium, is a pharmaceutical company that stands out with its certifications from WHO-GMP.
One of their notable products is SODIUM [1311] IODIDE (LEU FISSION), with a corresponding US DMF Number 36442.
Remarkably, this DMF maintains an Active status since its submission on January 21, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2025, and payment made on May 08, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
