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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | EUROAPI |
France |
EUROAPI FRANCE | 17264 | SPIRONOLACTONE | 2004-03-26 | Active | II | Complete | 2013-02-06 | 2013-01-23 |
24/02/2025 | ACS DOBFAR SPA |
Italy |
ANTIBIOTICOS SPA | 2657 | SPIRONOLACTONE | 1976-04-26 | Inactive | II | N/A |