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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