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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 EUROAPI
    France
    		 HVL PHARMA UK LIMITED 38198 SEVELAMER HYDROCHLORIDE 2023-06-27 Active II Complete 2023-12-20 2023-09-18
    29/01/2026 Ami Lifesciences Private Limited
    India
    		 AMI LIFESCIENCES PRIVATE LTD 38016 SEVELAMER HYDROCHLORIDE 2023-03-01 Active II N/A
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