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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 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 24590 | TADALAFIL | 2011-01-31 | Active | II | Complete | 2018-03-07 | 2017-11-15 |
24/02/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 37995 | TADALAFIL | 2023-02-10 | Active | II | N/A |