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List of Drug Master Files (DMF) of PREVANTICS SWABSTICK 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 Evonik
Germany
EVONIK OPERATIONS GMBH 8379 CHLORHEXIDINE DIGLUCONATE 1990-01-19 Active II N/A
26/09/2024 Medichem S.A
Spain
MEDICHEM SA 9701 CHLORHEXIDINE GLUCONATE 1992-05-27 Active II Complete 2013-01-11 2012-12-06