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List of Drug Master Files (DMF) of Buronil 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 H. Lundbeck AS
Denmark
LUNDBECK PHARMACEUTICALS ITALY SPA 20837 MELPERONE HYDROCHLORIDE 2007-07-27 Inactive II N/A