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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 Merck & Co
U.S.A
NV ORGANON 13895 TIBOLONE 1998-12-14 Inactive II N/A
28/03/2025 Qinhuangdao Zizhu Pharmaceutical
China
QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD 29217 TIBOLONE 2015-03-26 Active II N/A