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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
24/02/2025 Chifeng Arker Pharmaceutical Technology Co. Ltd.
China
CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD 18393 DIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE 2005-05-11 Inactive II N/A
24/02/2025 HUNAN JIUDIAN PHARMACEUTICAL CO LTD
China
HUNAN JIUDIAN PHARMACEUTICAL CO LTD 20584 DIRITHROMYCIN 2007-04-30 Active II N/A