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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | Helsinn Advanced Synthesis |
Switzerland |
HELSINN THERAPEUTICS US INC | 31120 | ANAMORELIN HYDROCHLORIDE (API) | 2016-11-16 | Active | II | N/A | ||
| 27/09/2025 | Helsinn Advanced Synthesis |
Switzerland |
HELSINN THERAPEUTICS US INC | 30961 | ANAMORELIN HYDROCHLORIDE, 100 MG TABLETS | 2016-11-16 | Active | II | N/A |
