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List of Drug Master Files (DMF) of CEFADROXIL/CEFADROXIL HEMIHYDRATE 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 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 13225 CEFADROXIL MONOHYDRATE 1998-04-30 Active II N/A
26/09/2024 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 13614 CEFADROXIL 1998-09-01 Inactive II N/A