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List of Drug Master Files (DMF) of SODIUM PHOSPHATE DIBASIC, ANHYDROUS 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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 38011 SODIUM PHOSPHATE DIBASIC HEPTAHYDRATE 2023-02-09 Active II Complete 2024-05-28 2024-04-27
26/09/2024 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 10195 PHOSPHATE SODIUM DIBASIC STERILE 1993-04-13 Inactive II N/A