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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
28/10/2024 Hybio Pharmaceutical
China
HYBIO PHARMACEUTICAL CO LTD 27265 NESIRITIDE CITRATE, NON-STERILE BULK DRUG SUBSTANCE 2013-06-25 Active II Complete 2014-10-07 2014-04-10
28/10/2024 Mallinckrodt Pharmaceuticals
Ireland
MALLINCKRODT CHEMICAL INC 10543 BRAIN NATRIURETIC PEPTIDE 1993-10-26 Inactive II N/A