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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 Ono Pharmaceutical
Japan
MARUISHI PHARMACEUTICAL CO LTD 27130 ALPROSTADIL ALFADEX 2013-04-26 Active II N/A
28/03/2025 Ono Pharmaceutical
Japan
ONO PHARMACEUTICAL CO LTD 10415 ALPROSTADIL ALFADEX I.V. 1993-08-10 Inactive II N/A