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List of Drug Master Files (DMF) of (1-hydroxy-1-phosphonoethyl)phosphonic acid 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 F. Hoffmann-La Roche
Switzerland
KV PHARMACEUTICAL CO 4215 DIDRONEL TABLETS, 200 MG, MNFG IN WESTPORT FACIL., ST.LOUIS, MISSOURI 1981-06-30 Inactive II N/A
26/09/2024 GANES CHEMICALS INC PENNSVILLE DIV 2676 DISODIUM ETIDRONATE 1976-05-20 Inactive II N/A