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List of Drug Master Files (DMF) of Tox21_300035 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Avanos
U.S.A
AVANOS MEDICAL 18942 [14C]-UREA, USP (PYTEST DRUG SUBSTANCE) 2005-11-08 Active II N/A
26/09/2024 BioSpectra
U.S.A
BIOSPECTRA 31669 UREA ACTIVE PHARMACEUTICAL INGREDIENT 2017-04-24 Active II N/A