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List of Drug Master Files (DMF) of Entresto 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 31574 SACUBITRIL/VALSARTAN 2017-08-29 Active II Complete 2017-12-22 2017-11-08
26/09/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 32337 SACUBITRIL/VALSARTAN COMPLEX 2017-12-21 Active II Complete 2018-09-04 2017-12-20