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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 | Sanofi |
France |
GENZYME PHARMACEUTICALS | 12055 | N-[2-(5-METHOXYINDOL-3-YL)ETHYL] ACETAMIDE (MELATONIN) | 1996-07-19 | Inactive | II | N/A | ||
| 27/09/2025 | Swati Spentose |
India |
SWATI SPENTOSE PRIVATE LTD | 34979 | MELATONIN USP | 2020-08-08 | Active | II | N/A |
