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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 | Aarti Pharmalabs |
India |
AARTI PHARMALABS LTD | 20502 | BICALUTAMIDE | 2007-05-01 | Active | II | Complete | 2023-11-22 | 2023-11-09 |
| 28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 17008 | BICALUTAMIDE | 2003-12-05 | Active | II | N/A |
