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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | DZD Heze Pharmaceutical Co Ltd |
China |
DZD (HEZE) PHARMACEUTICAL CO LTD | 34521 | VALRUBICIN | 2020-04-30 | Active | II | N/A | ||
28/10/2024 | Synbias Pharma Limited Liability Company |
Ukraine |
SYNBIAS PHARMA AG | 26918 | VALRUBICIN USP | 2013-02-26 | Active | II | Complete | 2013-12-04 | 2013-04-15 |
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