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List of Drug Master Files (DMF) of Alumino 4 Aminosalicylic Acid 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 Jacobus Pharmaceutical Company, Inc
U.S.A
JACOBUS PHARMACEUTICAL CO 11697 AMINOSALICYLATE SODIUM USP 1995-10-03 Inactive II N/A
26/09/2024 ZEELAND CHEMICALS INC 6909 PARA-AMINOSALICYLIC ACID, SODIUM 1987-04-03 Inactive II N/A