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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Pfanstiehl |
U.S.A |
PFANSTIEHL INC | 39584 | TRIS HYDROCHLORIDE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS (T-154) | 2024-03-01 | Active | IV | N/A | ||
| 29/11/2025 | BioSpectra |
U.S.A |
BIOSPECTRA | 31921 | TRIS HCL | 2017-08-09 | Active | IV | N/A |
