01 2Alembic Pharmaceuticals Limited
02 1Apotex Pharmachem
03 1AstraZeneca
04 1Aurobindo Pharma Limited
05 1Chromo Laboratories
06 1Hetero Drugs
07 1Jiangxi Synergy Pharmaceutical
08 1Jubilant Generics
09 1Lek Pharmaceuticals
10 1Macleods Pharmaceuticals Limited
11 1Parabolic Drugs
12 1RANBAXY LABORATORIES LIMITED
13 1TAPI Technology & API Services
14 1Torrent Pharmaceuticals Limited
15 2ULKAR KIMYA SANAYII VE TICARET
16 1Unimark Remedies Limited
17 1Viatris
18 1Zhejiang Huahai Pharmaceutical
19 2Zydus Lifesciences
01 10CANDESARTAN CILEXETIL
02 1CANDESARTAN CILEXETIL (NON STERILE BULK) DRUG SUBSTANCE
03 1CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE)
04 8CANDESARTAN CILEXETIL USP
05 1CANDESARTAN CILEXETIL USP (CND PROCESS)
06 1TCV-116
01 1Canada
02 2China
03 13India
04 1Israel
05 1Slovenia
06 2Turkey
07 1U.S.A
08 1United Kingdom
01 10Active
02 12Inactive
01 2Complete
02 20Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2016-02-10
DMF Number : 30240
Submission : 2016-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25797
Submission : 2012-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24810
Submission : 2011-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22672
Submission : 2009-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26996
Submission : 2013-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25216
Submission : 2011-08-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20400
Submission : 2007-04-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2012-11-23
DMF Number : 25455
Submission : 2011-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23693
Submission : 2010-04-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18828
Submission : 2005-10-03
Status : Active
Type : II
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