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List of Drug Master Files (DMF) of Epinastine 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 21974 EPINASTINE HCL 2008-12-30 Active II N/A
26/09/2024 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG 15003 EPINASTINE HYDROCHLORIDE 2000-09-11 Active II N/A