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List of Drug Master Files (DMF) of Lanoxin 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 Alchem International Private Ltd
India
ALCHEM INTERNATIONAL PRIVATE LTD 30724 DIGOXIN USP 2016-07-06 Active II Complete 2017-06-30 2017-05-04
26/09/2024 Deccan Nutraceuticals Pvt. Ltd
India
ALKALOIDS CORP 28628 DIGOXIN MICRO USP 2014-09-08 Active II Complete 2015-07-07 2014-10-26