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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 Anthem Biosciences
    India
    		 ANTHEM BIOSCIENCES PVT LTD 36528 CALCIUM L-5-METHYLTETRAHYDROFOLATE USP 2021-12-20 Active II Complete 2022-02-17 2021-12-14
    29/01/2026 Chemspec-API
    U.S.A
    		 CHEMSPEC API 25789 CALCIUM LEVOMEFOLATE 2013-03-01 Active II N/A
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