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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 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 39450 TUCATINIB HEMIETHANOLATE 2024-02-01 Active II Complete 2024-03-13 2024-02-13
28/10/2024 Teva Pharmaceutical Industries
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 39057 TUCATINIB 2023-10-26 Active II N/A