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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 SIMS Srl
Italy
SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL 5147 TETRAHYDROZOLINE HCl 1983-10-28 Active II N/A
28/10/2024 Zentiva
Czech Republic
ZENTIVA KS 15191 TETRAHYDROZOLINE HYDROCHLORIDE USP 2000-12-15 Inactive II N/A