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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 Novo Nordisk
    Denmark
    		 NOVO NORDISK AS 8133 SUBTILISIN A 1989-07-14 Inactive II N/A
    29/01/2026 DR REDDYS LABORATORIES LTD
    Gabon
    		 DR REDDYS LABORATORIES LTD 27213 TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYANO-2-AZABICYCLO[3.1.0]HEXAN-2-YL)1-((1R, 3R,5R,7S)-3-HYDROXYADAMANTAN-1-YL)-2-OXOETHYL) CARBAMATE 2013-09-12 Active II N/A
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