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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 20633 | CARVEDILOL PHOSPHATE HEMIHYDRATE | 2007-06-26 | Active | II | Complete | 2017-01-19 | 2016-12-07 |
25/04/2025 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 23312 | CARVEDILOL PHOSPHATE | 2009-11-25 | Active | II | Complete | 2013-06-06 | 2012-11-13 |