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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 |