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List of Drug Master Files (DMF) of L-Threonine 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 Ajinomoto Company
Japan
AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INC 31564 L-THREONINE 2017-03-21 Active II Complete 2021-04-30 2020-11-30
26/09/2024 Ajinomoto Company
Japan
SHANGHAI AJINOMOTO AMINO ACID CO LTD 29306 L-THREONINE 2015-04-17 Active II Complete 2017-05-12 2017-04-17