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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/02/2026 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 41091 | VORTIOXETINE HYDROBROMIDE | 2024-12-31 | Active | II | N/A | ||
| 27/02/2026 | Lundbeck CDM |
Denmark |
H LUNDBECK AS | 21224 | LU AA21004 HYDROBROMIDE | 2008-01-17 | Active | II | N/A |
