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List of Drug Master Files (DMF) of Lorcaserin 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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 30118 LORCASERIN HYDROCHLORIDE HEMIHYDRATE 2015-12-31 Active II Complete 2016-02-04 2015-12-29
26/09/2024 Lupin Ltd
India
LUPIN LTD 29910 LORCASERIN HYDROCHLORIDE PREMIX 2015-12-24 Inactive II N/A