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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
    28/10/2024 Aurobindo Pharma Limited
    India
    		 APITORIA PHARMA PRIVATE LTD 27401 ENTECAVIR 2013-08-31 Active II Complete 2013-10-10 2013-08-27
    28/10/2024 Chongqing Carelife Pharmaceutical
    China
    		 CHONGQING CARELIFE PHARMACEUTICAL CO LTD 24601 ENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE 2011-01-28 Active II Complete 2014-05-12 2013-05-21