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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 | Fareva |
Luxembourg |
EXCELLA GMBH AND CO KG | 21863 | BICALUTAMIDE MILLED Z | 2008-08-04 | Active | II | Complete | 2015-08-19 | 2015-08-10 |
28/10/2024 | Aarti Pharmalabs |
India |
AARTI PHARMALABS LTD | 20502 | BICALUTAMIDE | 2007-05-01 | Active | II | Complete | 2023-11-22 | 2023-11-09 |
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