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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
28/03/2025 BrightGene Bio-Medical Technology Co.,Ltd
China
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD 38815 FIDAXOMICIN 2023-09-28 Active II Complete 2024-01-04 2023-09-20
28/03/2025 BrightGene Bio-Medical Technology Co.,Ltd
China
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD 28803 FIDAXOMICIN CRYSTALLINE 2014-11-26 Active II Complete 2015-02-25 2014-11-24