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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/03/2025 | Erregierre SpA |
Italy |
ERREGIERRE SPA | 18707 | BUTENAFINE HYDROCHLORIDE | 2005-08-16 | Active | II | N/A | ||
| 28/03/2025 | Kaken Pharmaceuticals |
Japan |
KAKEN PHARMACEUTICAL CO LTD | 11296 | BUTENEAFINE HYDROCHLORIDE | 1995-01-09 | Active | II | N/A |
