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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 Granules India Limited
    India
    		 GRANULES INDIA LTD 39695 CALCIUM OXYBATE 2025-03-31 Active II Complete 2025-05-12 2025-04-22
    29/01/2026 Cambrex Corporation
    U.S.A
    		 CAMBREX CHARLES CITY INC 35873 CALCIUM OXYBATE 2022-06-10 Active II Complete 2022-06-30 2022-05-17
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