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List of Drug Master Files (DMF) of Opium 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 Cambrex Corporation
U.S.A
CAMBREX CHARLES CITY INC 27667 OPIUM TINCTURE 2% 2013-10-10 Active II N/A
26/09/2024 Mallinckrodt Pharmaceuticals
Ireland
SPECGX LLC 23883 OPIUM TINCTURE 2% 2010-08-04 Active II N/A