01 1Arene Lifesciences
02 1Aurobindo Pharma Limited
03 1Chongqing Carelife Pharmaceutical
04 1Chromo Laboratories
05 3Cipla
06 1Emcure Pharmaceuticals
07 2Hetero Drugs
08 3Laurus Labs
09 1Lek Pharmaceuticals
10 2Lupin Ltd
11 2MSN Laboratories
12 1Macleods Pharmaceuticals Limited
13 1Micro Labs Limited
14 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
15 1Styrax
16 2Viatris
17 1Viyash Life Sciences
01 17DOLUTEGRAVIR SODIUM
02 1DOLUTEGRAVIR SODIUM ( PROCESS B)
03 1DOLUTEGRAVIR SODIUM (FORM C)
04 1DOLUTEGRAVIR SODIUM (PROCESS A)
05 1DOLUTEGRAVIR SODIUM (PROCESS-2)
06 1DOLUTEGRAVIR SODIUM (PROCESS-3)
07 2DOLUTEGRAVIR SODIUM (PROCESS-II)
08 1DOLUTEGRAVIR SODIUM PROCESS A
01 2China
02 20India
03 1Slovenia
04 2U.S.A
01 25Active
01 19Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2014-10-10
DMF Number : 28721
Submission : 2014-10-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-01
Pay. Date : 2016-11-07
DMF Number : 31107
Submission : 2017-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-16
DMF Number : 30055
Submission : 2016-03-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-19
DMF Number : 30544
Submission : 2016-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-09-19
DMF Number : 30935
Submission : 2016-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-06
Pay. Date : 2016-11-25
DMF Number : 30933
Submission : 2016-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2017-01-10
DMF Number : 31222
Submission : 2017-01-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-02
Pay. Date : 2018-03-05
DMF Number : 30365
Submission : 2016-02-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-31
Pay. Date : 2017-05-11
DMF Number : 31209
Submission : 2016-12-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-26
Pay. Date : 2015-11-24
DMF Number : 30011
Submission : 2015-11-26
Status : Active
Type : II
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