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List of Drug Master Files (DMF) of Fosnetupitant chloride hydrochloride 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 Helsinn Advanced Synthesis
Switzerland
HAS HEALTHCARE ADVANCED SYNTHESIS SA 31323 FOSNETUPITANT CHLORIDE 2017-03-31 Active II N/A
26/09/2024 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 35788 FOSNETUPITANT CHLORIDE HYDROCHLORIDE 2021-06-09 Active II Complete 2022-04-05 2022-01-19