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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
27/02/2026 Cosma (C.F.M. Group)
Italy
COSMA SPA 4523 METOCLOPRAMIDE HYDROCHLORIDE 1982-05-03 Active II Complete 2018-03-02 2018-01-12
27/02/2026 Lundbeck CDM
Denmark
LUNDBECK PHARMACEUTICALS ITALY SPA 4877 METOCLOPRAMIDE HCL MONOHYDRATE 1983-03-26 Active II Complete 2016-07-28 2016-07-21