01 1AK AND MN BIOFARM CO LTD
02 4BASF
03 1CI NATURMEGA SA
04 1Catalent Pharma Solutions
05 1Chemport Inc
06 2Croda Europe Limited
07 2Huatai Biopharm Inc
08 1KinOmega Biopharm Inc.
09 1Olon S.p.A
10 1SOLUTEX GC SL
11 1Shandong Xinhua Pharmaceutical
12 1Shandong Yuwang
13 1Skuny Bioscience Co.,Ltd
01 1AK&MN BIOFARM OMEGA-3 ACID ETHYL ESTER
02 1LOVAZA 1 G SOFT GELATIN CAPSULES (OMEGA-3-ACID ETHYL ESTERS, 1 GRAM)
03 1OMEGA 3 ACID ETHYL ESTERS, USP
04 1OMEGA-3 ACID ETHYL ESTERS 78
05 1OMEGA-3 ACID ETHYL ESTERS 90
06 7OMEGA-3-ACID ETHYL ESTERS
07 1OMEGA-3-ACID ETHYL ESTERS (NON-STERILE, BULK FORM)
08 1OMEGA-3-ACID ETHYL ESTERS 90
09 1OMEGA-3-ACID ETHYL ESTERS CAPSULES
10 1OMEGA-3-ACID ETHYL ESTERS USP
11 1OMEGA-3-ACID TRIGLYCERIDES PH EUR
12 1OMEGA-3-ACID-ETHYL ESTERS
01 6China
02 4Germany
03 1Italy
04 1South Korea
05 1Spain
06 2U.S.A
07 3United Kingdom
01 14Active
02 4Inactive
01 7Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23510
Submission : 2010-04-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-13
Pay. Date : 2013-01-22
DMF Number : 23369
Submission : 2010-01-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2013-12-16
DMF Number : 26056
Submission : 2012-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-11-06
DMF Number : 25342
Submission : 2011-09-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28263
Submission : 2014-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-13
Pay. Date : 2021-02-03
DMF Number : 22106
Submission : 2008-10-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-10-21
DMF Number : 22285
Submission : 2008-10-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-08
Pay. Date : 2020-02-21
DMF Number : 26570
Submission : 2012-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29184
Submission : 2015-02-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-03-15
DMF Number : 28246
Submission : 2014-05-19
Status : Active
Type : II
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