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List of Drug Master Files (DMF) of Erythrityl Tetranitrate 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 The Mosaic Company
U.S.A
IMC CHEMICAL GROUP INC SUB INTERNATIONAL MINERALS CHEMICAL CORP 4143 ERYTHRITOL TETRANITRATE(ETN) MNFG IN SPANISH FORK, UTAH FACILITIES 1981-04-13 Inactive II N/A
26/09/2024 SOCIETE SUISSE DES EXPLOSIFS 4504 NITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE 1982-03-18 Inactive II N/A