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List of Drug Master Files (DMF) of Sulfasalazine 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 Bayer AG
Germany
PROQUINA SA 7242 SALAZOSULFAPYRIDINE 1987-11-09 Inactive II N/A
26/09/2024 Bayer AG
Germany
SCHERING AG 5145 SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT 1983-10-18 Inactive II N/A