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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/01/2025 | MSN Laboratories |
India |
MSN LIFE SCIENCES PRIVATE LTD | 41151 | SAMIDORPHAN L-MALATE | 2024-12-31 | Active | II | N/A | ||
| 28/01/2025 | Teva Pharmaceutical Industries |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 40848 | SAMIDORPHAN L-MALATE | 2024-12-19 | Active | II | N/A |
