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List of Drug Master Files (DMF) of 1,2-diaminocyclohexane platinum oxalate 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 Veranova
U.S.A
VERANOVA LP 16952 OXALIPLATIN 2003-11-11 Active II N/A
26/09/2024 Fresenius Kabi AB Brunna
Sweden
FRESENIUS KABI ONCOLOGY LTD 19610 OXALIPLATIN 2006-07-17 Active II Complete 2014-12-19 2014-12-16