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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 | Axplora |
Germany |
FARMABIOS SPA | 25933 | BUSULFAN | 2012-03-27 | Active | II | Complete | 2013-08-08 | 2012-12-17 |
24/02/2025 | Apicore LLC |
India |
APICORE US LLC | 23924 | BUSULFAN USP | 2010-08-05 | Active | II | Complete | 2015-06-10 | 2015-05-27 |