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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 | Erregierre SpA |
Italy |
ERREGIERRE SPA | 14297 | GEPIRONE HYDROCHLORIDE | 1999-07-09 | Active | II | N/A | ||
| 25/04/2025 | Maithri Drugs |
India |
MAITHRI LABORATORIES PRIVATE LTD | 41514 | GEPIRONE HYDROCHLORIDE | 2025-03-25 | Active | II | N/A |
