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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 | Merck & Co |
U.S.A |
NV ORGANON | 13895 | TIBOLONE | 1998-12-14 | Inactive | II | N/A | ||
28/10/2024 | Qinhuangdao Zizhu Pharmaceutical |
China |
QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD | 29217 | TIBOLONE | 2015-03-26 | Active | II | N/A |
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