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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 20709 | ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE | 2007-07-20 | Active | II | Complete | 2019-12-27 | 2019-12-20 |
| 25/04/2025 | Curia |
U.S.A |
CURIA ITALY SRL | 40227 | ARGATROBAN MONOHYDRATE | 2024-08-30 | Active | II | Complete | 2024-10-15 | 2024-09-10 |
