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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 Apotex Pharmachem
    Canada
    		 APOTEX INC 31843 TASIMELTEON 2017-07-31 Active II Complete 2017-10-30 2017-07-26
    29/01/2026 MSN Laboratories
    India
    		 MSN LIFE SCIENCES PRIVATE LTD 31948 TASIMELTEON 2017-08-30 Active II Complete 2017-10-05 2017-09-22
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