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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 |