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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
29/01/2026 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 8625 DEXBROMPHENIRAMINE MALEATE 1990-06-28 Active II N/A
29/01/2026 Industriale Chimica
Italy
INDUSTRIA CHIMICA MILANESE SPA 4799 DEXBROMPHENIRAMINE MALEATE USP. XX 1982-11-22 Inactive II N/A