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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 Noramco
U.S.A
NORAMCO LLC 22992 NALTREXONE DRUG SUBSTANCE 2009-07-28 Active II Complete 2016-04-23 2016-04-07
29/11/2025 Siegfried AG
Switzerland
SIEGFRIED AG 40414 NALTREXONE 2024-12-20 Active II Complete 2025-02-13 2024-11-15