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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 | ZACH System SA |
France |
ZACH SYSTEM SA | 24929 | BOSENTAN MONOHYDRATE | 2011-05-09 | Active | II | Complete | 2014-08-25 | 2014-01-31 |
| 28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 26038 | BOSENTAN MONOHYDRATE | 2012-05-09 | Active | II | Complete | 2015-10-13 | 2015-07-09 |
