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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 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 13884 IDARUBICIN HYDROCHLORIDE 1998-12-07 Active II Complete 2012-11-29 2012-11-08
28/03/2025 Exopharm
Australia
EXOPHARM CO LTD 19185 IDARUBICIN HYDROCHLORIDE, USP NON-STERILE BULK DRUG SUBSTANCE 2006-02-08 Inactive II N/A