01 1Acebright India Pharma Private Limited
02 1Alembic Pharmaceuticals Limited
03 1Aurisco Pharmaceutical
04 1Aurobindo Pharma Limited
05 1Chongqing Carelife Pharmaceutical
06 3Cipla
07 1Emcure Pharmaceuticals
08 1HEC Pharm
09 1Hetero Drugs
10 2Laurus Labs
11 2Lupin Ltd
12 1MSN Laboratories
13 2Macleods Pharmaceuticals Limited
14 1Micro Labs Limited
15 1Reyoung pharmaceutical
16 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
17 1Shilpa Medicare
18 2Viatris
19 1Wuhan Calmland Pharmaceuticals
01 12TENOFOVIR ALAFENAMIDE FUMARATE
02 1TENOFOVIR ALAFENAMIDE FUMARATE (C)
03 1TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-2)
04 1TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-B)
05 1TENOFOVIR ALAFENAMIDE FUMARATE NON-STERILE BULK DRUG SUBSTANCE
06 1TENOFOVIR ALAFENAMIDE FUMARATE [DRUG SUBSTANCE (NON-STERILE)].
07 1TENOFOVIR ALAFENAMIDE FUMARATE, NON-STERILE BULK DRUG SUBSTANCE
08 4TENOFOVIR ALAFENAMIDE HEMIFUMARATE
09 1TENOFOVIR ALAFENAMIDE MONOFUMARATE
10 1TENOFOVIR ALAFENMIDE FUMARATE
11 1TENOFOVIR ALAFERNAMIDE MONOFUMARATE
01 6China
02 17India
03 2U.S.A
01 25Active
01 18Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-09-29
DMF Number : 30991
Submission : 2016-10-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-30
Pay. Date : 2018-06-18
DMF Number : 32312
Submission : 2017-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-12-06
DMF Number : 31167
Submission : 2016-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-03
Pay. Date : 2019-02-14
DMF Number : 33541
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-01
Pay. Date : 2017-05-18
DMF Number : 31516
Submission : 2017-04-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32493
Submission : 2018-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-01
Pay. Date : 2018-06-27
DMF Number : 32726
Submission : 2018-06-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-01
Pay. Date : 2019-07-08
DMF Number : 33316
Submission : 2018-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-30
Pay. Date : 2018-11-08
DMF Number : 31700
Submission : 2017-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-03
Pay. Date : 2015-11-24
DMF Number : 30013
Submission : 2015-12-24
Status : Active
Type : II
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