Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
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 | Medichem S.A |
Spain |
MEDICHEM SA | 18052 | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 2005-02-01 | Active | II | Complete | 2015-10-08 | 2015-09-14 |
28/10/2024 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INC | 21440 | PAROXETINE HYDROCHLORIDE ANHYDROUS USP | 2008-03-18 | Active | II | N/A |
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