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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
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 30118 LORCASERIN HYDROCHLORIDE HEMIHYDRATE 2015-12-31 Active II Complete 2016-02-04 2015-12-29
28/03/2025 Lupin Ltd
India
LUPIN LTD 29910 LORCASERIN HYDROCHLORIDE PREMIX 2015-12-24 Inactive II N/A