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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 16582 | FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE) | 2003-05-12 | Active | II | N/A | ||
| 31/10/2025 | Cambridge Major Laboratories |
Netherlands |
SAGE CHEMICALS INC | 16145 | FENOLDOPAM MESYLATE USP | 2002-09-24 | Active | II | N/A |
