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    Promethazine Hydrochloride

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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
    28/03/2025 Egis Pharmaceuticals PLC
    Hungary
    		 EGIS PHARMACEUTICALS PLC 7882 PROMETHAZINE HCL 1989-01-24 Active II Complete 2021-06-10 2021-06-07
    28/03/2025 Sanofi
    France
    		 SANOFI WINTHROP INDUSTRIE 1949 PROMETHAZINE HCL 1972-06-09 Active II Complete 2013-02-26 2013-02-13