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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 16053 | ESMOLOL HCL | 2002-06-27 | Active | II | Complete | 2013-01-18 | 2012-12-17 |
| 28/03/2025 | Axplora |
Germany |
FINORGA SAS | 6868 | ESMOLOL HYDROCHLORIDE | 1987-01-20 | Active | II | Complete | 2020-02-28 | 2020-02-24 |
