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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 | Actylis |
U.S.A |
PHARMA-WALDHOF GMBH | 4959 | 5-FLUORO-URACIL,PRODUCT 4965 | 1983-05-18 | Inactive | II | N/A | ||
28/03/2025 | Amcol |
U.S.A |
AMCOL HEALTH AND BEAUTY SOLUTIONS INC | 29443 | POLY-PORE® FLUOROURACIL POLYMER | 2015-11-13 | Active | II | Complete | 2017-07-07 | 2015-07-08 |