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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 | Pfanstiehl |
U.S.A |
PFANSTIEHL INC | 38161 | MALTOSE MONOHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, JP, CHP | 2023-03-10 | Active | IV | N/A | ||
24/02/2025 | Hayashibara |
Japan |
HAYASHIBARA CO LTD | 15648 | HAYASHIBARA MALTOSE MONOHYDRATE FOR INJECTION | 2001-10-05 | Active | IV | N/A |