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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 | Medichem S.A |
Spain |
MEDICHEM SA | 18052 | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 2005-02-01 | Active | II | Complete | 2015-10-08 | 2015-09-14 |
28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 16416 | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 2003-02-06 | Inactive | II | N/A |