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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Sanofi |
France |
GENZYME PHARMACEUTICALS | 12055 | N-[2-(5-METHOXYINDOL-3-YL)ETHYL] ACETAMIDE (MELATONIN) | 1996-07-19 | Inactive | II | N/A | ||
| 25/04/2025 | Biosynth AG |
Switzerland |
BIOSYNTH AG | 11014 | MELATONIN AND A STABILITY INDICATION ASSAY METHOD FOR MELATONIN | 1994-07-28 | Inactive | II | N/A |
