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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | EUROAPI |
France |
EUROAPI UK LTD | 38198 | SEVELAMER HYDROCHLORIDE | 2023-06-27 | Active | II | Complete | 2023-12-20 | 2023-09-18 |
24/02/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 38016 | SEVELAMER HYDROCHLORIDE | 2023-03-01 | Active | II | N/A |