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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
28/10/2024 Macrocyclics
U.S.A
MACROCYCLICS INC 35952 DOTAMTATE DRUG SUBSTANCE 2021-05-20 Active II N/A
28/10/2024 Oranomed
U.S.A
ORANO MED LLC 35863 212Pb-DOTAMTATE DRUG PRODUCT 2021-05-20 Active II N/A