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List of Drug Master Files (DMF) of Polyethylene Glycol 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 Avesta Pharma
India
AVESTA PHARMA PVT LTD 27419 POLYETHYLENE GLYCOL 3350 USP 2013-08-12 Active II Complete 2014-05-05 2013-09-26
26/09/2024 Clariant
Switzerland
CLARIANT PRODUKTE DEUTSCHLAND GMBH 13091 MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF) 1998-07-23 Active II N/A