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List of Drug Master Files (DMF) of 2-Nitro-4,5-Dihydro-1,3-Thiazole 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 Archimica
Italy
ARCHIMICA SPA 10531 NITRO-THIAZOLINEBULK 1993-10-19 Inactive II N/A
26/09/2024 FERMENTACIONES Y SINTESIS ESPANOLAS SA 10864 NITRO-THIAZOLINE 1994-04-11 Inactive II N/A