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List of Drug Master Files (DMF) of Calcium Oxybate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 762Xls 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 Cambrex Corporation
U.S.A
CAMBREX CHARLES CITY INC 35873 CALCIUM OXYBATE 2022-06-10 Active II Complete 2022-06-30 2022-05-17