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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
    19/01/2026 Siegfried AG
    Switzerland
    		 SIEGFRIED EVIONNAZ SA 16127 MEFLOQUINE HYDROCHLORIDE 2002-09-06 Active II N/A
    30/12/2025 Emcure Pharmaceuticals
    India
    		 EMCURE PHARMACEUTICALS LTD 22138 MEFLOQUINE HYDROCHLORIDE USP 2008-10-23 Inactive II N/A
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