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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 Ahk Tech
    China
    		 CHANGZHOU AHK TECH INC 22873 AMIFOSTINE 2009-05-26 Inactive II N/A
    29/01/2026 Axitec
    China
    		 AXITEC CO LTD 18898 AMIFOSTINE USP (NON-STERILE BULK DRUG) 2005-10-08 Inactive II N/A
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