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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 | Aspen API |
Netherlands |
ASPEN OSS BV | 10457 | MIRTAZAPINE | 1993-08-30 | Active | II | N/A | ||
| 28/03/2025 | Medichem S.A |
Spain |
MEDICHEM SA | 15749 | MIRTAZAPINE | 2001-12-05 | Active | II | Complete | 2013-04-30 | 2013-04-17 |
