01 3Haoyuan Chemexpress Co.Ltd
02 1Levena Biopharma
03 1WuXi AppTec
04 1Zhejiang Huida Biotech
01 1MMAE (HM-297C_22)
02 1MMAE-1 (HM-297C_19, INTERMEDIATE OF VC-MMAE)
03 1MMAE-3 (HM-297C_12, INTERMEDIATE OF VC-MMAE)
04 1MONOMETHYL AURISTATIN E (MMAE)
05 1Monomethyl Auristatin E
06 1“MONOMETHYL AURISTATIN E (MMAE)”
01 6China
01 6Active
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35549
Submission : 2021-08-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35548
Submission : 2021-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 36741
Submission : 2022-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 37623
Submission : 2022-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36104
Submission : 2021-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38481
Submission : 2023-07-17
Status : Active
Type : II
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