01 1Acebright India Pharma Private Limited
02 1Aurisco Pharmaceutical
03 1Aurobindo Pharma Limited
04 1Chromo Laboratories
05 2Cipla
06 2Emcure Pharmaceuticals
07 2Hetero Drugs
08 3Laurus Labs
09 1Lupin Ltd
10 1Macleods Pharmaceuticals Limited
11 1Qilu Antibiotics Pharmaceutical Co., Ltd.
12 1RANBAXY LABORATORIES LIMITED
13 1SEQUENT SCIENTIFIC LTD
14 1Shanghai Desano Bio-Pharmaceutical
15 1Shijiazhuang Lonzeal Pharmac.Co. ltd
16 1Solara Active Pharma Sciences
17 1Styrax
18 1Tyche Industries Ltd
19 1Unimark Remedies Limited
20 2Viatris
21 1Viyash Life Sciences
22 1Zhejiang Candorly Pharmaceutical
23 1Zhejiang Huahai Pharmaceutical
24 1Zhejiang Supor Pharmaceuticals Co., LTD
01 1TENOFOVIR DISOPROXIL FUMARATE
02 21TENOFOVIR DISOPROXIL FUMARATE
03 1TENOFOVIR DISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE)
04 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS B)
05 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS II)
06 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS-2)
07 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS-3)
08 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS-II)
09 1TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE
10 1TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)]
01 7China
02 21India
03 2U.S.A
01 24Active
02 6Inactive
01 16Complete
02 14Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-01
Pay. Date : 2017-10-10
DMF Number : 21096
Submission : 2007-11-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-28
Pay. Date : 2018-09-24
DMF Number : 24852
Submission : 2011-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-20
DMF Number : 20003
Submission : 2006-11-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-12-03
DMF Number : 21540
Submission : 2008-04-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-17
Pay. Date : 2013-05-13
DMF Number : 27087
Submission : 2013-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-21
Pay. Date : 2013-02-04
DMF Number : 25787
Submission : 2012-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24764
Submission : 2011-03-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2013-11-26
DMF Number : 25304
Submission : 2011-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26083
Submission : 2012-05-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-21
Pay. Date : 2013-05-14
DMF Number : 20108
Submission : 2007-01-03
Status : Active
Type : II
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