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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 | Fareva |
Luxembourg |
EXCELLA GMBH AND CO KG | 10945 | ACYCLOVIR SODIUM | 1994-06-09 | Active | II | Complete | 2015-02-20 | 2013-09-26 |
28/03/2025 | Fidia Farmaceutici Spa |
Italy |
FIDIA FARMACEUTICI SPA | 11829 | ACYCLOVIR SODIUM SALT | 1996-01-24 | Inactive | II | N/A |