01 1Arene Lifesciences
02 1Aurobindo Pharma Limited
03 1Cipla
04 1Emcure Pharmaceuticals
05 1HONOUR LAB LTD
06 2Hetero Drugs
07 1Laurus Labs
08 1Lupin Ltd
09 1Macleods Pharmaceuticals Limited
10 1RANBAXY LABORATORIES LIMITED
11 1Shanghai Desano Bio-Pharmaceutical
12 1Shijiazhuang Lonzeal Pharmac.Co. ltd
13 3Viatris
14 1Vivin Drugs
01 11EMTRICITABINE
02 1EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE
03 2EMTRICITABINE (PROCESS-II)
04 1EMTRICITABINE (PROCESS-III)
05 1EMTRICITABINE DRUG SUBSTANCE
06 1EMTRICITABINE USP
01 2China
02 12India
03 3U.S.A
01 13Active
02 4Inactive
01 10Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-01
Pay. Date : 2017-10-11
DMF Number : 20708
Submission : 2007-07-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-24
Pay. Date : 2014-03-19
DMF Number : 19785
Submission : 2006-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-28
Pay. Date : 2015-05-14
DMF Number : 21612
Submission : 2008-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-17
DMF Number : 23773
Submission : 2010-04-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-10
Pay. Date : 2013-02-04
DMF Number : 22944
Submission : 2009-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25001
Submission : 2011-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-05
Pay. Date : 2013-02-07
DMF Number : 25617
Submission : 2011-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-23
Pay. Date : 2017-03-01
DMF Number : 31457
Submission : 2017-03-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-05
Pay. Date : 2013-09-20
DMF Number : 27455
Submission : 2013-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-21
Pay. Date : 2013-05-14
DMF Number : 19566
Submission : 2006-06-30
Status : Active
Type : II
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