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List of Drug Master Files (DMF) of Ruxolitinib 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 Changzhou Pharmaceutical Factory
China
CHANGZHOU PHARMACEUTICAL FACTORY 39763 RUXOLITINIB PHOSPHATE 2024-03-27 Active II N/A
26/09/2024 Chongqing Huapont Pharmaceutical
China
CHONGQING HUAPONT PHARMACEUTICAL CO LTD 29480 RUXOLITINIB PHOSPHATE 2015-05-29 Active II Complete 2015-11-16 2015-07-31