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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Noramco |
U.S.A |
NORAMCO LLC | 22992 | NALTREXONE DRUG SUBSTANCE | 2009-07-28 | Active | II | Complete | 2016-04-23 | 2016-04-07 |
| 29/11/2025 | Siegfried AG |
Switzerland |
SIEGFRIED AG | 40414 | NALTREXONE | 2024-12-20 | Active | II | Complete | 2025-02-13 | 2024-11-15 |
