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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 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 24395 CEFEPIME FOR INJECTION (STERILE BULK) 2011-03-31 Active II Complete 2016-08-15 2016-07-05
28/03/2025 Antibioticos do Brasil Ltda
Brazil
ANTIBIOTICOS DO BRASIL LTDA 19806 CEFEPIME FOR INJECTION USP (STERILE BULK) 2006-09-26 Active II Complete 2013-06-24 2013-06-14