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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 Centrient Pharmaceuticals
Netherlands
CENTRIENT PHARMACEUTICALS NETHERLANDS BV 13210 CEPHALEXIN MONOHYDRATE 1998-04-30 Active II Complete 2013-01-11 2013-01-11
28/03/2025 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 13612 CEPHALEXIN MONOHYDRATE 1998-09-01 Active II Complete 2017-03-17 2017-02-27