01 1Apotex Pharmachem
02 1Aurobindo Pharma Limited
03 1BrightGene Bio-Medical Technology Co.,Ltd
04 1Chongqing Carelife Pharmaceutical
05 1Cipla
06 1Fuxin Long Rui Pharmaceutical
07 1Hetero Drugs
08 1Kyongbo Pharmaceutical Co., Ltd
09 1Lek Pharmaceuticals
10 1Lianyungang Runzhong Pharmaceutical Co Ltd
11 1ScinoPharm Taiwan, Ltd
12 3Wisdom Pharmaceutical
13 1Yung Shin Pharmaceutical Industrial
14 1Zhejiang Ausun Pharmaceutical
15 1Zhejiang Huahai Pharmaceutical
16 1Zydus Lifesciences
01 4ENTECAVIR
02 1ENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE
03 1ENTECAVIR INTERMEDIATE
04 5ENTECAVIR MONOHYDRATE
05 1ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE
06 2ENTECAVIR MONOHYDRATE USP
07 1ENTECAVIR NON STERILE BULK DRUG SUBSTANCE
08 3ENTECAVIR USP
01 1Canada
02 10China
03 4India
04 1Slovenia
05 1South Korea
06 1Taiwan
01 14Active
02 4Inactive
01 12Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-10
Pay. Date : 2013-08-27
DMF Number : 27401
Submission : 2013-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-12
Pay. Date : 2013-05-21
DMF Number : 24601
Submission : 2011-01-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 23663
Submission : 2010-05-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-03-18
DMF Number : 26307
Submission : 2012-08-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-23
Pay. Date : 2013-11-21
DMF Number : 27719
Submission : 2013-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-28
Pay. Date : 2013-07-02
DMF Number : 25549
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-03-12
DMF Number : 27600
Submission : 2014-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-10-30
DMF Number : 25200
Submission : 2011-08-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-21
Pay. Date : 2014-10-14
DMF Number : 27848
Submission : 2014-01-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-23
Pay. Date : 2013-12-06
DMF Number : 27767
Submission : 2013-12-26
Status : Active
Type : II
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