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List of Drug Master Files (DMF) of Alserin 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 Indena
Italy
INDENA SPA 4942 RESERPINE USP 1983-04-29 Active II Complete 2015-03-25 2014-07-07
26/09/2024 Mallinckrodt Pharmaceuticals
Ireland
MALLINCKRODT INC 192 RESERPINE 1956-02-02 Inactive II N/A