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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 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 31166 | APIXABAN | 2016-11-16 | Active | II | Complete | 2017-02-10 | 2016-12-20 |
28/10/2024 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 30336 | APIXABAN | 2016-03-14 | Active | II | Complete | 2016-08-15 | 2016-03-28 |
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