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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 | Alivus Life Sciences |
India |
GLENMARK LIFE SCIENCES LTD | 34741 | SOLRIAMFETOL HYDROCHLORIDE | 2020-03-31 | Active | II | Complete | 2022-12-16 | 2022-11-14 |
| 28/03/2025 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 36951 | Solriamfetol Hydrochloride | 2022-03-28 | Active | II | Complete | 2023-02-15 | 2023-02-03 |
