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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 American Peptide Company
    U.S.A
    		 BACHEM AMERICAS INC 17669 PEPTIDE 312868 (TP508) 2004-09-08 Inactive II N/A
    29/01/2026 Beckman Coulter
    U.S.A
    		 BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORP 4826 SYNTHETIC HUMAN PROINSULIN C-PEPTIDE 1983-02-25 Inactive II N/A
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