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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 American Pacific Corporation
U.S.A
AMPAC FINE CHEMICALS LLC 28580 TEMOZOLOMIDE 2014-09-25 Active II Complete 2019-06-12 2019-04-30
28/03/2025 Beijing Lunarsun Pharmaceutical Co., Ltd
China
BEIJING LUNARSUN PHARMACEUTICAL CO LTD 24352 TEMOZOLOMIDE 2010-11-09 Active II N/A