01 1ALP Pharm
02 1Alembic Pharmaceuticals Limited
03 1Alkem Laboratories
04 1Aurobindo Pharma Limited
05 1HEC Pharm
06 1HONOUR LAB LTD
07 2Jiangxi Synergy Pharmaceutical
08 1Jubilant Generics
09 1Lupin Ltd
10 2MSN Laboratories
11 1Piramal Pharma Solutions
12 1Reyoung pharmaceutical
13 1Takeda Pharmaceutical
14 1Zhejiang Tianyu Pharmaceutical Co., Ltd
15 1Blank
01 3AZILSARTAN
02 7AZILSARTAN KAMEDOXOMIL
03 1AZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE
04 1AZILSARTAN KAMEDOXOMIL [ROUTE CODE "AK"]
05 1AZILSARTAN MEDOXOMIL
06 1AZILSARTAN MEDOXOMIL MONOPOTASSIUM
07 2AZILSARTAN MEDOXOMIL POTASSIUM
08 1TAK-536 DRUG SUBSTANCE
01 6China
02 8India
03 1Japan
04 1U.S.A
05 1Blank
01 16Active
02 1Inactive
01 7Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-10
Pay. Date : 2015-06-26
DMF Number : 29488
Submission : 2015-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29818
Submission : 2015-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-21
Pay. Date : 2020-09-28
DMF Number : 35239
Submission : 2020-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-08-26
DMF Number : 28452
Submission : 2014-08-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-08-08
DMF Number : 31895
Submission : 2017-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29785
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-12
Pay. Date : 2019-06-05
DMF Number : 33732
Submission : 2019-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35932
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-06
Pay. Date : 2021-06-23
DMF Number : 28092
Submission : 2014-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-13
Pay. Date : 2021-08-26
DMF Number : 35770
Submission : 2021-03-31
Status : Active
Type : II
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