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List of Drug Master Files (DMF) of Prevacid 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 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 35485 LANSOPRAZOLE USP 2020-12-22 Active II N/A
26/09/2024 Moehs Iberica
Spain
MOEHS IBERICA SL 17819 LANSOPRAZOLE 2004-11-02 Active II Complete 2017-12-01 2017-10-05