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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
24/02/2025 Fermion Oy
Finland
FERMION OY 11315 FLUOXETINE HYDROCHLORIDE USP 1995-01-26 Active II Complete 2014-10-13 2014-10-02
24/02/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 12146 FLUOXETINE HCI 1996-10-02 Active II Complete 2017-02-22 2017-02-06