01 1Alembic Pharmaceuticals Limited
02 1Cdymax
03 1Cipla
04 1Hetero Drugs
05 2MSN Laboratories
06 1Natco Pharma
07 1Qilu Antibiotics Pharmaceutical Co., Ltd.
08 1SYNTHON Chemicals GmbH & Co. KG
09 1ScinoPharm Taiwan, Ltd
10 1Sichuan Xieli Pharmaceutical
11 1Yabao Pharmaceutical Group Co. Ltd
12 1Zhejiang Hisun Pharmaceutical
13 1Zhejiang Jiuzhou Pharmaceutical
01 13GEFITINIB
02 1GEFITINIB [ROUTE CODE GN]
01 5China
02 1Germany
03 7India
04 1Taiwan
01 13Active
02 1Inactive
01 9Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-13
Pay. Date : 2016-09-08
DMF Number : 30868
Submission : 2016-09-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-09-13
DMF Number : 29090
Submission : 2015-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-23
Pay. Date : 2018-01-04
DMF Number : 32274
Submission : 2017-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-25
Pay. Date : 2016-09-30
DMF Number : 29670
Submission : 2015-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-11
Pay. Date : 2015-09-24
DMF Number : 29772
Submission : 2015-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31941
Submission : 2017-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-05
Pay. Date : 2015-12-23
DMF Number : 26456
Submission : 2012-09-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-27
Pay. Date : 2015-11-19
DMF Number : 29797
Submission : 2015-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28613
Submission : 2014-09-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-28
Pay. Date : 2016-06-15
DMF Number : 30518
Submission : 2016-04-28
Status : Active
Type : II
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