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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Aspen API |
Netherlands |
FINE CHEMICALS CORP PTY LTD | 6309 | THIOTHIXENE | 1986-05-05 | Active | II | Complete | 2019-09-26 | 2019-09-13 |
25/04/2025 | Nuray Chemicals Private Limited |
India |
NOVITIUM PHARMA LLC | 31839 | THIOTHIXENE USP | 2017-07-21 | Active | II | Complete | 2017-10-11 | 2017-07-06 |