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01 1Apicore LLC
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1MSN Laboratories
04 1Natco Pharma
05 1PharmaMar
06 1Wisdom Pharmaceutical
07 1Xiling Lab
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01 7LURBINECTEDIN
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01 3China
02 3India
03 1Spain
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01 7Active
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01 3Complete
02 4Blank
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
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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
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DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 39620
Submission : 2024-09-06
Status : Active
Type : II
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