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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 Metrochem API Private Limited
    India
    		 METROCHEM API PRIVATE LTD 41086 VORTIOXETINE HYDROCHLORIDE 2024-12-31 Active II N/A
    29/01/2026 Cohance Lifesciences
    India
    		 COHANCE LIFESCIENCES LTD 29211 ATOMOXETINE HYDROCHLORIDE USP 2015-03-26 Active II Complete 2019-12-27 2019-12-03
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