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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 | Roquette |
France |
ROQUETTE FRERES | 34930 | SORBITOL POWDER PYROGEN FREE | 2020-06-09 | Active | II | Complete | 2024-12-30 | 2024-09-05 |
28/03/2025 | Roquette |
France |
ROQUETTE AMERICA INC | 10879 | NEOSORB 70/20 SORBITOL SOLUTION | 1994-04-15 | Inactive | IV | N/A |