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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 | ZACH System SA |
France |
ZACH SYSTEM SA | 11105 | LOTEPREDNOL ETABONATE | 1994-09-26 | Active | II | Complete | 2024-10-16 | 2024-10-08 |
28/03/2025 | Axplora |
Germany |
FARMABIOS SPA | 26937 | LOTEPREDNOL ETABONATE | 2013-03-05 | Active | II | N/A |