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List of Drug Master Files (DMF) of NCGC00024995-03 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Phyton Biotech LLC
Canada
PHYTON BIOTECH LLC 16374 SEMI-SYNTHETIC PACLITAXEL API 2003-01-21 Active II N/A
26/09/2024 Axplora
Germany
SERIPHARM SAS 12294 PACLITAXEL 1996-12-27 Active II N/A