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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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    Eslicarbazepine Acetate

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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
    30/12/2025 Ami Lifesciences Private Limited
    India
    		 AMI LIFESCIENCES PRIVATE LTD 38309 ESLICARBAZEPINE ACETATE 2023-04-25 Active II N/A
    30/12/2025 Dr. Reddy\'s Laboratories
    India
    		 DR REDDYS LABORATORIES LTD 31758 ESLICARBAZEPINE ACETATE 2017-05-31 Active II Complete 2017-07-05 2017-06-19
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