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List of Drug Master Files (DMF) of 012C11ZU6G Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 150Xls download

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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 15887 TERBINAFINE HYDROCHLORIDE USP 2002-03-06 Active II N/A
26/09/2024 Taro Pharmaceutical Industries
U.S.A
TARO PHARMACEUTICAL INDUSTRIES LTD 30940 TERBINAFINE HYDROCHLORIDE , USP 2017-03-23 Active II Complete 2017-05-15 2017-03-23