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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 | Jiangsu Hengrui Medicine |
China |
JIANGSU HENGRUI PHARMACEUTICALS CO LTD | 34108 | IOVERSOL USP, NON-STERILE, BULK DRUG SUBSTANCE | 2019-09-30 | Inactive | II | N/A | ||
| 29/11/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
LIEBEL-FLARSHEIM CO LLC | 12259 | IOVERSOL, DRUG SUBSTANCE FOR OPTIRAY | 1996-12-06 | Active | II | N/A |
