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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 Pfanstiehl
    U.S.A
    		 PFANSTIEHL INC 39484 TRIS BASE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, CHP (T-153) 2024-01-31 Active IV N/A
    29/01/2026 AVT (Shanghai)
    China
    		 AVT (SHANGHAI) PHARMACEUTICAL TECH CO LTD 38022 TROMETAMOL HYDROCHLORIDE 2023-04-11 Active IV N/A
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