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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 Neuland Laboratories
India
NEULAND LABORATORIES LTD 25543 EZETIMIBE USP (FORM-X) 2011-11-30 Active II Complete 2018-08-14 2018-07-05
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 20039 EZETIMIBE 2006-12-13 Active II Complete 2013-04-17 2013-04-04