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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 Hetero Drugs
India
HETERO LABS LTD 42016 AXITINIB (FORM-XLI) 2025-11-05 Active II N/A
27/02/2026 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 29672 AXITINIB [ROUTE CODE - "XA"] 2015-09-29 Active II Complete 2015-12-18 2015-09-23