01 1Alembic Pharmaceuticals Limited
02 1Beijing Hope Pharmaceutical
03 1Cipla
04 1Esteve Huayi Pharmaceutical
05 1Fresenius Kabi Oncology Limited
06 1Hetero Drugs
07 4MSN Laboratories
08 1Natco Pharma
09 1ScinoPharm Taiwan, Ltd
10 1Shilpa Medicare
11 1Sun Pharmaceutical Industries Limited
12 1Teva API
13 2Wisdom Pharmaceutical
01 10IBRUTINIB
02 1IBRUTINIB (AMORPHOUS)
03 1IBRUTINIB (FORM C)
04 1IBRUTINIB (FORM S4)
05 2IBRUTINIB (FORM-A)
06 1IBRUTINIB (FORM-M5)
07 1IBRUTINIB (IBN)
01 4China
02 11India
03 1Israel
04 1Taiwan
01 15Active
02 2Inactive
01 9Complete
02 8Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-06-06
DMF Number : 32880
Submission : 2018-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2017-05-08
DMF Number : 31679
Submission : 2017-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-08-14
DMF Number : 31689
Submission : 2017-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30557
Submission : 2016-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30759
Submission : 2016-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-09-22
DMF Number : 30925
Submission : 2016-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-02
Pay. Date : 2017-10-12
DMF Number : 32122
Submission : 2017-10-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-29
Pay. Date : 2017-03-27
DMF Number : 31547
Submission : 2017-09-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-05
Pay. Date : 2017-04-17
DMF Number : 31631
Submission : 2017-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31917
Submission : 2017-07-20
Status : Active
Type : II
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