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List of Drug Master Files (DMF) of disodium [3-amino-1-hydroxy-1-[hydroxy(oxido)phosphoryl]propyl]-hydroxyphosphinate 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 12803 PAMIDRONIC ACID 1997-12-22 Active II Complete 2012-12-24 2012-11-19
26/09/2024 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 19901 PAMIDRONIC ACID 2006-10-17 Inactive II N/A