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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 13087 | INAMRINONE USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE | 1998-07-24 | Active | II | N/A | ||
| 29/11/2025 | Archimica |
Italy |
ARCHIMICA SPA | 13193 | AMRINONE, USP | 1998-09-22 | Inactive | II | N/A |
