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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 | Fermion Oy |
Finland |
FERMION OY | 4246 | METHOTREXATE | 1981-08-06 | Active | II | Complete | 2013-06-08 | 2013-05-23 |
24/02/2025 | Pfanstiehl |
U.S.A |
PFANSTIEHL INC | 39988 | METHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1) | 2024-06-05 | Active | II | N/A |