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List of Drug Master Files (DMF) of Azilsartan Medoxomil 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 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 29488 AZILSARTAN MEDOXOMIL MONOPOTASSIUM 2015-06-30 Active II Complete 2015-09-10 2015-06-26
26/09/2024 ALP Pharm
China
ALP PHARM BEIJING CO LTD 29818 AZILSARTAN MEDOXOMIL 2015-09-24 Active II N/A