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List of Drug Master Files (DMF) of Oxtriphylline 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 Abbott Laboratories
U.S.A
KNOLL AG LUDWIGSHAFEN 4013 CHOLINE THEOPHYLLINATE (OXTRIPHYLLINE) 1980-12-15 Inactive II N/A
26/09/2024 ORGAMOL PHARMA SOLUTIONS SA
Switzerland
ORGAMOL SA 3475 CHOLINE THEOPHYLLINATE 1978-12-22 Inactive II N/A