01 1Apicore LLC
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1Extrovis AG
04 1Haoyuan Chemexpress Co.Ltd
05 1Jiangsu Hengrui Medicine
06 1Johnson & Johnson Innovative Medicine
07 1MSN Laboratories
08 1PharmaMar
01 5TRABECTEDIN
02 1TRABECTEDIN (HM-326A_42)
03 1TRABECTEDIN (R279741)
04 1TRABECTEDIN, NON-STERILE, BULK DRUG SUBSTANCE
01 3China
02 2India
03 1Spain
04 1Switzerland
05 1U.S.A
01 6Active
02 2Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-06-07
DMF Number : 35828
Submission : 2021-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39165
Submission : 2023-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39511
Submission : 2024-02-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-03
Pay. Date : 2023-01-19
DMF Number : 36724
Submission : 2022-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33677
Submission : 2019-05-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22020
Submission : 2008-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-08
Pay. Date : 2020-08-31
DMF Number : 34311
Submission : 2019-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21755
Submission : 2008-06-23
Status : Active
Type : II
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