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List of Drug Master Files (DMF) of n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate 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 Malladi Drugs & Pharmaceuticals Limited
India
MALLADI DRUGS AND PHARMACEUTICALS LTD 38487 DOXYLAMINE SUCCINATE 2023-12-26 Active II Complete 2024-07-03 2024-06-14
26/09/2024 Corden Pharma Bergamo S.p.A
Italy
CORDEN PHARMA BERGAMO SPA 4741 DOXYLAMINE SUCCINATE 1982-11-15 Active II N/A