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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
    31/10/2025 ChemWerth Inc
    U.S.A
    		 CHEMWERTH INC 37565 FOSPHENYTOIN SODIUM USP 2023-03-20 Active II Complete 2023-05-03 2023-03-30
    31/10/2025 Cilag AG
    Switzerland
    		 CILAG AG 18954 FOSPHENYTOIN SODIUM DRUG SUBSTANCE (A PHARMACEUTICAL INGREDIENT) 2005-11-14 Inactive II N/A