01 1Apicore LLC
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1Extrovis AG
04 2Haoyuan Chemexpress Co.Ltd
05 1Jiangsu Hengrui Medicine
06 1Johnson & Johnson Innovative Medicine
07 2Lonza Group
08 1MSN Laboratories
09 1PharmaMar
01 1ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE)
02 1ETH06 (TRABECTEDIN INTERMEDIATE)
03 1INTERMEDIATE OF TRABECTEDIN
04 5TRABECTEDIN
05 1TRABECTEDIN (HM-326A_42)
06 1TRABECTEDIN (R279741)
07 1TRABECTEDIN, NON-STERILE, BULK DRUG SUBSTANCE
01 4China
02 2India
03 1Spain
04 3Switzerland
05 1U.S.A
01 7Active
02 4Inactive
01 3Complete
02 8Blank
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 36899
Submission : 2022-11-16
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 : 22020
Submission : 2008-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27694
Submission : 2013-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21642
Submission : 2008-05-16
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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