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List of Drug Master Files (DMF) of Clemastine (fumarate) 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 Sanofi
France
RHONE POULENC RORER PHARMACEUTICALS INC 3321 FUMARATE (30,356 R.P.) 1978-08-30 Inactive II N/A
26/09/2024 DAITO CORP
Japan
DAITO PHARMACEUTICALS CO LTD 6862 CLEMASTINE FUMERATE 1987-03-02 Inactive II N/A