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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
28/10/2024 F.I.S. Fabbrica Italiana Sintetici
Italy
FIS FABBRICA ITALIANA SINTETICI SPA 20266 TERBINAFINE HCL 2007-01-29 Inactive II N/A
28/10/2024 Novartis Pharmaceuticals Corporation
Switzerland
NOVARTIS PHARMACEUTICALS CORP 27059 TERBINAFINE 2013-06-07 Active II N/A