01 1BrightGene Bio-Medical Technology Co.,Ltd
02 1Haoyuan Chemexpress Co.Ltd
03 1Levena Biopharma
04 1WuXi AppTec
05 1Zhejiang Huida Biotech
06 1Blank
01 1EXATECAN MESYLATE
02 2EXATECAN MESYLATE
03 1EXATECAN MESYLATE (HM-582_10)
04 1LND1030 (EXATECAN MESYLATE)
05 1PAYLOAD-LINKER EXATECAN MESYLATE
01 5China
02 1Blank
01 6Active
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37214
Submission : 2022-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36708
Submission : 2022-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37905
Submission : 2022-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37610
Submission : 2023-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36614
Submission : 2022-01-03
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37906
Submission : 2023-07-31
Status : Active
Type : II
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