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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 Maithri Drugs
    India
    		 MAITHRI DRUGS PRIVATE LTD 41266 POTASSIUM SULFATE 2025-01-31 Active II Complete 2025-11-28 2025-09-29
    29/01/2026 Emnar Pharma
    India
    		 EMNAR PHARMA PRIVATE LTD 42697 POTASSIUM SULFATE 2025-10-17 Active II N/A
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