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    Ursodiol [USAN:USP]

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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
    27/09/2025 ICE Pharma
    Italy
    		 ICE SPA 16803 URSODIOL 2003-09-03 Active II Complete 2019-03-25 2019-02-14
    27/09/2025 PharmaZell
    Germany
    		 PHARMAZELL GMBH 40626 URSODIOL 2024-12-18 Active II Complete 2025-01-30 2024-12-16