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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
31/03/2026 Otsuka Chemical Co Ltd
Japan
OTSUKA PHARMACEUTICAL CO LTD 4820 PROCATEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORY 1983-01-17 Inactive II N/A
31/03/2026 Otsuka Chemical Co Ltd
Japan
OTSUKA PHARMACEUTICAL CO LTD 3606 PROCATEROL HYDROCHLORIDE HEMIHYDRATE 1979-09-19 Inactive II N/A