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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 | MSN Laboratories |
India |
MSN LIFE SCIENCES PRIVATE LTD | 41151 | SAMIDORPHAN L-MALATE | 2024-12-31 | Active | II | Complete | 2025-01-27 | 2025-01-13 |
| 28/03/2025 | Teva Pharmaceutical Industries |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 40848 | SAMIDORPHAN L-MALATE | 2024-12-19 | Active | II | Complete | 2025-02-04 | 2024-11-21 |
