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List of Drug Master Files (DMF) of potassium 2,3,4,5,6-pentahydroxyhexanoate 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 Pfanstiehl
U.S.A
PFANSTIEHL INC 9147 SODIUM GLUCONATE, USP (S-108) 1991-05-31 Active II Complete 2021-09-14 2021-09-09
26/09/2024 Roquette
France
ROQUETTE FRERES 34499 SODIUM GLUCONATE 2020-01-15 Active II N/A