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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 ApiSyn
India
APISYN HEALTHCARE PRIVATE LTD 42362 LINEZOLID (FORM-II) 2025-11-27 Active II N/A
27/02/2026 Neuland Laboratories
India
NEULAND LABORATORIES LTD 24506 LINEZOLID USP (FORM-II) 2010-12-29 Active II Complete 2014-06-27 2014-06-23