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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 Bayer AG
    Germany
    		 BAYER AG 6174 GESTODENE 1985-12-19 Inactive II N/A
    29/01/2026 Qinhuangdao Zizhu Pharmaceutical
    China
    		 QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD 29345 GESTODENE (MICRONIZED) 2015-06-08 Active II N/A
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