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

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$ API Ref.Price (USD/KG) : 1,297Xls 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 Inke S.A
Spain
INKE SA 16317 ONDANSETRON HYDROCHLORIDE 2002-12-13 Active II N/A
26/09/2024 Dr. Reddy\\\'s Laboratories
India
DR REDDYS LABORATORIES LTD 15436 ONDANSETRON HYDROCHLORIDE DIHYDRATE USP 2001-05-15 Active II Complete 2015-09-23 2015-09-09