01 1Alembic Pharmaceuticals Limited
02 1Fresenius Kabi Oncology Limited
03 2Hetero Drugs
04 1MSN Laboratories
05 1Qilu Antibiotics Pharmaceutical Co., Ltd.
06 1Sun Pharmaceutical Industries Limited
07 1TAPI Technology & API Services
01 6AFATINIB DIMALEATE
02 1AFATINIB DIMALEATE (FORM A)
03 1AFATINIB DIMALEATE MONOHYDRATE (FORM-R)
01 1China
02 6India
03 1Israel
01 7Active
02 1Inactive
01 6Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-27
DMF Number : 31848
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30927
Submission : 2016-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37111
Submission : 2022-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-30
Pay. Date : 2017-04-28
DMF Number : 31611
Submission : 2017-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
Pay. Date : 2017-03-24
DMF Number : 31285
Submission : 2016-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-21
Pay. Date : 2019-02-12
DMF Number : 33080
Submission : 2019-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-29
Pay. Date : 2017-04-28
DMF Number : 31515
Submission : 2017-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-28
Pay. Date : 2017-01-10
DMF Number : 31302
Submission : 2017-01-12
Status : Active
Type : II
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