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

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$ API Ref.Price (USD/KG) : 88Xls 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 Sanofi
France
SANOFI CHIMIE 9382 ACEBUTOLOL HYDROCHLORIDE 1991-10-23 Inactive II N/A
26/09/2024 Nuray Chemicals Private Limited
India
SS PHARMA LLC 35857 ACEBUTOLOL HYDROCHLORIDE USP 2021-04-30 Active II Complete 2021-06-16 2021-04-30