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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 | Axplora |
Germany |
FARMABIOS SPA | 18352 | HALCINONIDE | 2005-05-13 | Active | II | Complete | 2016-11-10 | 2016-09-29 |
28/03/2025 | Bristol Myers Squibb |
U.S.A |
BRISTOL MYERS SQUIBB CO | 2203 | HALCINONIDE BULK | 1973-12-21 | Inactive | II | N/A |