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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
25/04/2025 Apicore
India
APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC) 39948 PHENTOLAMINE MESYLATE USP 2024-06-07 Active II N/A
25/04/2025 CordenPharma
Germany
SYNKEM DIV PLASTO SA 11936 PHENTOLAMINE MESYLATE 1996-04-19 Inactive II N/A