01 1AR Life Sciences
02 1Alembic Pharmaceuticals Limited
03 2Aurobindo Pharma Limited
04 1Cipla
05 1Glenmark Life Sciences
06 1Lupin Ltd
07 1MSN Laboratories
08 1ScinoPharm Taiwan, Ltd
09 1Sun Pharmaceutical Industries Limited
10 2Vindhya Organics
01 14-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID [STARTING MATERIAL OF IVACAFTOR]
02 14-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID/IVF-3P
03 1AMINO PHENOL DERIVATIVE [STARTING MATERIAL OF IVACATOR]
04 7IVACAFTOR
05 1IVACAFTOR PREMIX
06 1IVACAFTOR [ROUTE CODE - 'IC']
01 11India
02 1Taiwan
01 12Active
01 7Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-28
DMF Number : 31849
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35586
Submission : 2021-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-13
Pay. Date : 2021-07-07
DMF Number : 36094
Submission : 2021-07-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-19
Pay. Date : 2015-03-10
DMF Number : 28867
Submission : 2015-03-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-20
Pay. Date : 2020-07-02
DMF Number : 32610
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-17
Pay. Date : 2023-08-29
DMF Number : 29398
Submission : 2015-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35447
Submission : 2020-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-10
Pay. Date : 2019-07-25
DMF Number : 33783
Submission : 2019-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35587
Submission : 2021-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35551
Submission : 2021-01-25
Status : Active
Type : II
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