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List of Drug Master Files (DMF) of Prestwick2_000881 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 6Xls 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 Aarti Drugs
India
AARTI DRUGS LTD 20051 NIACIN 2006-12-14 Active II Complete 2013-04-10 2013-04-03
26/09/2024 Divis Laboratories
India
DIVIS LABORATORIES LTD 18481 NIACIN USP 2005-07-05 Active II Complete 2013-01-08 2012-12-06