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List of Drug Master Files (DMF) of Droxidopa 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 Clarochem Ireland
Ireland
CLAROCHEM IRELAND LTD 33459 DROXIDOPA 2019-01-04 Active II Complete 2019-03-20 2019-01-31
26/09/2024 Dasami Lab
India
DASAMI LAB PRIVATE LTD 35368 DROXIDOPA (PROCESS-II) 2020-11-27 Active II Complete 2021-01-10 2020-11-25