01 1Isotope Technologies Munich
01 1LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTION
01 1Germany
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-23
Pay. Date : 2023-06-20
DMF Number : 35008
Submission : 2020-09-21
Status : Active
Type : II
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Itm Medical Isotopes Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTION, with a corresponding US DMF Number 35008.
Remarkably, this DMF maintains an Active status since its submission on September 21, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2023, and payment made on June 20, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
