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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
30/12/2025 ABX Advanced Biochemical Compounds
Germany
ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH 40281 [18O] WATER 2024-09-16 Active II N/A
30/12/2025 Cambridge Isotope Laboratories
U.S.A
CAMBRIDGE ISOTOPE LABORATORIES INC 17418 OXYGEN-18 ENRICHED WATER, CIL PART NUMBER OLM-240 2004-05-26 Inactive II N/A