Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 36951 | Solriamfetol Hydrochloride | 2022-03-28 | Active | II | Complete | 2023-02-15 | 2023-02-03 |
| 28/10/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 37929 | SOLRIAMFETOL HYDROCHLORIDE | 2023-01-10 | Active | II | Complete | 2023-04-28 | 2023-01-09 |
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