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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 Malladi Drugs & Pharmaceuticals Limited
    India
    		 MALLADI DRUGS AND PHARMACEUTICALS LTD 33271 EPHEDRINE SULFATE 2019-01-14 Active II Complete 2019-10-28 2019-02-01
    29/01/2026 Siegfried AG
    Switzerland
    		 SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH 28283 (-)-EPHEDRINE SULFATE 2014-05-05 Active II Complete 2015-12-04 2015-02-17
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