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List of Drug Master Files (DMF) of DSSTox_CID_3340 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 Fareva
Luxembourg
EXCELLA GMBH AND CO KG 21079 MYCOPHENOLATE MOFETIL SIEVED 2007-11-28 Active II N/A
26/09/2024 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 18494 MYCOPHENOLATE MOFETIL USP 2005-07-11 Active II Complete 2017-02-01 2016-11-22