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List of Drug Master Files (DMF) of L-Arginine Hydrochloride API 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
SHANGHAI AJINOMOTO AMINO ACID CO LTD 39436 L-ARGININE MONOHYDROCHLORIDE 2024-04-30 Active IV N/A
26/09/2024 Ajinomoto Company
Japan
AJINOMOTO CO INC 31647 L-ARGININE MONOHYDROCHLORIDE 2017-04-20 Active II N/A