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List of Drug Master Files (DMF) of Guanethidine 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 Corden Pharma Bergamo S.p.A
Italy
FARCHEMIA SRL 5122 GUANETHIDINE SULFATE, USP 1983-08-26 Inactive II N/A
26/09/2024 DINAMITE DIPHARMA SPA 5070 GUANETHIDINE MONOSULFATE 1983-07-26 Inactive II N/A