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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 |
ASPEN OSS BV | 10457 | MIRTAZAPINE | 1993-08-30 | Active | II | N/A | ||
25/04/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 16007 | MIRTAZAPINE | 2002-06-11 | Active | II | N/A |