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    List of Drug Master Files (DMF) of (2S,6S)-9-chloro-4-methyl-13-oxa-4-azatetracyclo[12.4.0.0^{2,6}.0^{7,12}]octadeca-1(14),7(12),8,10,15,17-hexaene; maleic acid Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    (2S,6S)-9-chloro-4-methyl-13-oxa-4-azatetracyclo[12.4.0.0^{2,6}.0^{7,12}]octadeca-1(14),7(12),8,10,15,17-hexaene; maleic acid

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    $ API Ref.Price (USD/KG) : 30,418Xls download

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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
    26/09/2024 Aspen API
    Netherlands
    		 ASPEN OSS BV 34868 ASENAPINE MALEATE 2020-06-10 Active II N/A
    26/09/2024 Medichem S.A
    Spain
    		 MEDICHEM SA 26923 MED-200056/E 2013-05-16 Active II Complete 2013-11-01 2013-05-01