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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
28/01/2025 Phyton Biotech LLC
Canada
PHYTON BIOTECH LLC 24675 DOCETAXEL ANHYDROUS 2011-02-15 Active II Complete 2013-11-13 2013-02-22
28/01/2025 Chongqing Sintaho Pharmaceutical
China
CHONGQING SINTAHO PHARMACEUTICAL CO LTD 37224 DOCETAXEL 2022-06-27 Active II N/A