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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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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
    29/01/2026 PMC Isochem
    France
    		 ISOCHEM SAS 18056 GEMFIBROZIL 2005-02-03 Active II N/A
    29/01/2026 TAPI Technology & API Services
    Israel
    		 TAPI NL BV 7445 GEMFIBROZIL USP 1988-04-22 Active II N/A
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