01 1Alembic Pharmaceuticals Limited
02 1Aurobindo Pharma Limited
03 1HONOUR LAB LTD
04 1Laurus Labs
05 1MSN Laboratories
06 1Raks Pharma
07 1Seasons Biotechnology
08 1TAPI Technology & API Services
09 1Viatris
10 1Zhejiang Guobang Pharmaceutical
11 1Zhejiang Huayi Pharmaceutical Co., Ltd.
12 1Zydus Lifesciences
01 11MACITENTAN
02 1MACITENTAN [ROUTE CODE IM]
01 3China
02 7India
03 1Israel
04 1U.S.A
01 12Active
01 10Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-05
Pay. Date : 2017-04-17
DMF Number : 31664
Submission : 2017-04-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-01
Pay. Date : 2017-05-12
DMF Number : 31749
Submission : 2017-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-28
DMF Number : 31213
Submission : 2017-01-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-12
Pay. Date : 2017-08-30
DMF Number : 31957
Submission : 2017-09-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-22
Pay. Date : 2016-09-29
DMF Number : 30212
Submission : 2016-01-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-24
Pay. Date : 2016-12-05
DMF Number : 31179
Submission : 2016-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-22
Pay. Date : 2017-06-05
DMF Number : 31658
Submission : 2017-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-03
Pay. Date : 2017-02-22
DMF Number : 31416
Submission : 2017-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-04
Pay. Date : 2016-09-27
DMF Number : 30969
Submission : 2016-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-10
Pay. Date : 2017-04-21
DMF Number : 31463
Submission : 2017-04-01
Status : Active
Type : II
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