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List of Drug Master Files (DMF) of Nabumetone 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 Actavis Inc
Ireland
TEVA PHARMACEUTICAL INDUSTRIES LTD 22258 NABUMETONE USP 2008-12-22 Active II N/A
26/09/2024 Chemi SpA
Italy
CHEMI SPA 12296 NABUMETONE 1996-12-23 Inactive II N/A