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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 Axplora
    Germany
    		 PHARMAZELL GMBH 8070 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE) 1989-05-09 Active II Complete 2014-12-16 2014-11-28
    28/10/2024 Zhejiang Hengkang Pharmaceutical
    China
    		 ZHEJIANG HENGKANG PHARMACEUTICAL CO LTD 37319 MESALAMINE USP 2022-08-17 Active II Complete 2022-10-20 2022-09-16