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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 33180 | EMPAGLIFLOZIN | 2018-09-27 | Active | II | Complete | 2019-02-15 | 2018-10-09 |
28/10/2024 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 35345 | EMPAGLIFLOZIN | 2020-10-31 | Active | II | N/A |
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