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List of Drug Master Files (DMF) of Alvimopan 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 Actavis Inc
Ireland
TEVA PHARMACEUTICAL INDUSTRIES LTD 30553 ALVIMOPAN DIHYDRATE 2016-05-24 Active II Complete 2016-07-19 2016-05-18
26/09/2024 ALP Pharm
China
ALP PHARM BEIJING CO LTD 25908 ALVIMOPAN DIHYDRATE 2012-04-02 Inactive II N/A