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List of Drug Master Files (DMF) of Bismuth Subsalicylate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 24Xls download

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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 5N Plus Lubeck GmbH
Canada
5N PLUS LUBECK GMBH 36384 BISMUTH SUBSALICYLATE SG FINE 2021-12-15 Active II N/A
26/09/2024 5N Plus Lubeck GmbH
Canada
5N PLUS LUBECK GMBH 16327 BISMUTH SUBSALICYLATE SG 2002-12-23 Active II N/A