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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 | Avanos |
U.S.A |
AVANOS MEDICAL | 18942 | [14C]-UREA, USP (PYTEST DRUG SUBSTANCE) | 2005-11-08 | Active | II | N/A | ||
28/03/2025 | BioSpectra |
U.S.A |
BIOSPECTRA | 31669 | UREA ACTIVE PHARMACEUTICAL INGREDIENT | 2017-04-24 | Active | II | N/A |