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List of Drug Master Files (DMF) of Dobutamine HCl 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 8856 DOBUTAMINE HYDROCHLORIDE 1990-11-20 Active II N/A
26/09/2024 Sanofi
France
HOECHST MARION ROUSSEL SA 12528 DOBUTAMINE ISONICOTINATE/ OFF-0358-A-01-1 1997-05-30 Inactive II N/A