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

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    Betadex Sulfobutyl Ether Sodium Excipient

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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 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 34905 BETADEX SULFOBUTYL ETHER SODIUM USP 2020-06-01 Active IV N/A
    29/01/2026 GLAND PHARMA LIMITED
    India
    		 GLAND PHARMA LTD 30714 BETADEX SULFOBUTYL ETHER SODIUM USP- NF 2016-09-27 Active IV N/A
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