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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
28/11/2024 Chongqing Carelife Pharmaceutical
China
CHONGQING CARELIFE PHARMACEUTICAL CO LTD 38816 DACOMITINIB 2023-11-24 Active II Complete 2024-09-30 2024-08-26
28/11/2024 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 35213 DACOMITINIB MONOHYDRATE 2020-09-29 Active II N/A