01 1PCAS
02 1Aurobindo Pharma Limited
03 2Emcure Pharmaceuticals
04 1Hainan Poly Pharm
05 1Hetero Drugs
06 2Jubilant Generics
07 1Lunan Pharmaceutical
08 1MSN Laboratories
09 1Sterile India Pvt. Ltd
10 1Sun Pharmaceutical Industries Limited
11 1UQUIFA
12 1Yangtze River Pharmaceutical Group
13 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
14 1Zydus Lifesciences
01 10ESOMEPRAZOLE SODIUM
02 1ESOMEPRAZOLE SODIUM (NON-STERILE BULK DRUG SUBSTANCE)
03 1ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE)
04 1ESOMEPRAZOLE SODIUM (PROCESS II)
05 1ESOMEPRAZOLE SODIUM (STERILE)
06 1ESOMEPRAZOLE SODIUM NON-STERILE BULK DRUG SUBSTANCE
07 1ESOMPERAZOLE SODIUM [ROUTE CODE EU]
01 4China
02 1France
03 10India
04 1Spain
01 13Active
02 3Inactive
01 6Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28375
Submission : 2014-06-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2012-12-26
DMF Number : 26102
Submission : 2012-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-09
Pay. Date : 2013-08-19
DMF Number : 27388
Submission : 2013-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 24918
Submission : 2011-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24641
Submission : 2011-02-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-06-16
DMF Number : 23628
Submission : 2010-05-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30075
Submission : 2015-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29974
Submission : 2016-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-21
Pay. Date : 2020-05-13
DMF Number : 23199
Submission : 2009-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-22
Pay. Date : 2015-03-11
DMF Number : 29082
Submission : 2015-02-05
Status : Active
Type : II
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