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List of Drug Master Files (DMF) of 4-amino-5-fluoropyrimidin-2-ol 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 Actylis
U.S.A
ACETO CORP 15476 FLUCYTOSINE USP 2001-06-07 Inactive II N/A
26/09/2024 Calyx Chemicals & Pharmaceuticals Limited
India
CALYX CHEMICALS AND PHARMACEUTICALS LTD 23503 FLUCYTOSINE 2010-01-22 Active II N/A