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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
28/10/2024 Archimica
Italy
ARCHIMICA SPA 12754 HYDROXYUREA 1997-11-14 Active II Complete 2019-02-13 2019-02-08
28/10/2024 Bristol Myers Squibb
U.S.A
BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE 2452 HYDREA 1975-05-21 Inactive II N/A