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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
04/06/2025 | Honour Lab |
India |
HONOUR LAB LTD | 31213 | MACITENTAN | 2017-01-05 | Active | II | Complete | 2017-02-27 | 2016-12-28 |
04/06/2025 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 31416 | MACITENTAN | 2017-04-13 | Active | II | Complete | 2017-05-03 | 2017-02-22 |