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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 | F.I.S. Fabbrica Italiana Sintetici |
Italy |
FIS FABBRICA ITALIANA SINTETICI SPA | 20266 | TERBINAFINE HCL | 2007-01-29 | Inactive | II | N/A | ||
| 28/03/2025 | Novartis Pharmaceuticals Corporation |
Switzerland |
NOVARTIS PHARMACEUTICALS CORP | 27059 | TERBINAFINE | 2013-06-07 | Active | II | N/A |
