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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