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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 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 34418 | OXCARBAZEPINE | 2019-12-20 | Active | II | Complete | 2020-08-04 | 2020-02-03 |
28/03/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 38017 | OXCARBAZEPINE | 2023-03-15 | Active | II | Complete | 2025-03-04 | 2025-01-30 |