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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Pfanstiehl |
U.S.A |
PFANSTIEHL INC | 38409 | L-HISTIDINE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, CHP | 2023-05-25 | Active | IV | N/A | ||
25/04/2025 | Pfanstiehl |
U.S.A |
PFANSTIEHL INC | 39170 | L-HISTIDINE HYDROCHLORIDE MONOHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, BP, EP, JP, CHP (H-117) | 2023-11-28 | Active | IV | N/A |