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List of Drug Master Files (DMF) of 1-Hydroxyethyl-2-methyl-5-nitroimidazole 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 Sanofi
France
RHONE POULENC INC 780 METRONIDAZOLE 1964-02-07 Inactive II N/A
26/09/2024 B.Braun
India
MCGAW INC 3904 METRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES 1980-08-04 Inactive II N/A