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List of Drug Master Files (DMF) of Lactulose Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 3Xls download

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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 Abbott Laboratories
U.S.A
ABBOTT LABORATORIES CO 10145 LACTULOSE CONCENTRATE USP 1993-03-19 Active II N/A
26/09/2024 DANIPHARM A S
Denmark
DANIPHARM AS 8760 LACTULOSE CONCENTRATE 1990-09-20 Active II Complete 2017-03-28 2016-09-30