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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
28/03/2025 Lunan Pharmaceutical
China
SHANDONG NEW TIME PHARMACEUTICAL CO LTD 35057 OTERACIL POTASSIUM 2021-01-23 Active II N/A
28/03/2025 Sumitomo Chemical
Japan
SUMITOMO CHEMICAL CO LTD 13908 POTASSIUM OTASTAT 1998-12-22 Inactive II N/A