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List of Drug Master Files (DMF) of Altretamine [USAN:INN:BAN] 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 CHEMSYN CHEMICAL CORPORATION
Canada
CHEMSYN SCIENCE LABORATORIES 9703 ALTRETAMINE 1992-05-29 Inactive II N/A
26/09/2024 F. Hoffmann-La Roche
Switzerland
KV PHARMACEUTICAL CO 4412 HEXASTAT CAPS, 50 & 100MG 1981-12-18 Inactive II N/A