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List of Drug Master Files (DMF) of NCGC00024697-05 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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 Avanti Polar Lipids, Inc.
U.S.A
AVANTI POLAR LIPIDS INC 16766 N-HEXANOYL-D-ERYTHRO-SPHINGOSINE (C6 CERAMIDE) 2003-08-15 Inactive II N/A