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

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    Vonoprazan Fumarate (TAK-438)

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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 Metrochem API Private Limited
    India
    		 METROCHEM API PRIVATE LTD 35150 VONOPRAZAN FUMARATE 2020-08-31 Active II N/A
    29/01/2026 Zhejiang Hengkang Pharmaceutical
    China
    		 ZHEJIANG HENGKANG PHARMACEUTICAL CO LTD 40356 VONOPRAZON FUMARATE 2024-12-29 Active II N/A
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