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List of Drug Master Files (DMF) of Ropivacaine HCl 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 20249 ROPIVACAINE HCL MONOHYDRATE 2007-02-02 Active II Complete 2013-08-13 2013-08-05
26/09/2024 Aspen API
Netherlands
FINE CHEMICALS CORP PTY LTD 20654 ROPIVACAINE HYDROCHLORIDE 2007-07-03 Active II Complete 2016-12-19 2016-11-18