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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
    04/02/2026 Hisun Pharmaceutical (Hangzhou) Co.,Ltd.
    China
    		 HISUN PHARMACEUTICAL (HANGZHOU) CO LTD 43346 ORITAVANCIN NUCLEUS ACETATE 2025-12-26 Active II N/A
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