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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 |