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List of Drug Master Files (DMF) of Prochlorperazine Edisylate 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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 32178 PROCHLORPERAZINE EDISYLATE 2017-10-31 Active II Complete 2017-11-29 2017-11-06
26/09/2024 Sanofi
France
SANOFI INC 3545 PROCHLORPERAZINE EDISYLATE 1979-05-25 Inactive II N/A