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List of Drug Master Files (DMF) of 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 161Xls 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 Hubei Gedian Humanwell Pharmaceutical
China
HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD 32999 OXCARBAZEPINE 2018-07-22 Active II Complete 2019-04-12 2019-02-12
26/09/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 34418 OXCARBAZEPINE 2019-12-20 Active II Complete 2020-08-04 2020-02-03