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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 Alchem International Private Ltd
    India
    		 ALCHEM INTERNATIONAL PRIVATE LTD 30724 DIGOXIN USP 2016-07-06 Active II Complete 2017-06-30 2017-05-04
    29/01/2026 Deccan Nutraceuticals Pvt. Ltd
    India
    		 ALKALOIDS CORP 28628 DIGOXIN MICRO USP 2014-09-08 Active II Complete 2015-07-07 2014-10-26
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