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List of Drug Master Files (DMF) of Ranolazine 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 Dr. Reddy\\\'s Laboratories
India
DR REDDYS LABORATORIES LTD 23621 RANOLAZINE 2010-03-10 Active II Complete 2014-04-28 2013-05-09
26/09/2024 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 37339 RANOLAZINE 2022-08-18 Active II N/A