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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
28/10/2024 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INDIA PVT LTD 24305 ENTECAVIR USP 2010-10-19 Inactive II N/A
28/10/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 27401 ENTECAVIR 2013-08-31 Active II Complete 2013-10-10 2013-08-27