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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 33180 | EMPAGLIFLOZIN | 2018-09-27 | Active | II | Complete | 2019-02-15 | 2018-10-09 |
| 25/04/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 41197 | EMPAGLIFLOZIN | 2025-01-30 | Active | II | N/A |
