01 1Apicore LLC
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1MSN Laboratories
04 1Natco Pharma
05 1PharmaMar
06 1Wisdom Pharmaceutical
01 6LURBINECTEDIN
01 2China
02 3India
03 1Spain
01 6Active
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-28
Pay. Date : 2024-01-16
DMF Number : 39171
Submission : 2024-01-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39228
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-08
Pay. Date : 2024-04-18
DMF Number : 39672
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
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