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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 39979 UPADACITINIB HEMIHYDRATE 2024-07-30 Active II N/A
    29/01/2026 Aurobindo Pharma Limited
    India
    		 APITORIA PHARMA PRIVATE LTD 38095 UPADACITINIB 2023-02-22 Active II Complete 2023-04-24 2023-02-21
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