01 1Arene Lifesciences
02 1Aurobindo Pharma Limited
03 1Chromo Laboratories
04 3Cipla
05 1Emcure Pharmaceuticals
06 2Hetero Drugs
07 3Laurus Labs
08 1Lek Pharmaceuticals
09 2Lupin Ltd
10 2MSN Laboratories
11 1Macleods Pharmaceuticals Limited
12 1Micro Labs Limited
13 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
14 1Styrax
15 2Viatris
16 1Viyash Life Sciences
01 16DOLUTEGRAVIR 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 1China
02 20India
03 1Slovenia
04 2U.S.A
01 24Active
01 19Complete
02 5Blank
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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