01 1Alembic Pharmaceuticals Limited
02 1Gilead Sciences
03 2MSN Laboratories
04 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
05 2Viatris
01 4ELVITEGRAVIR
02 1ELVITEGRAVIR (FORM-I)
03 1ELVITEGRAVIR (FORM-II)
04 1ELVITEGRAVIR (PROCESS-II)
01 1China
02 3India
03 3U.S.A
01 7Active
01 3Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34649
Submission : 2020-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31090
Submission : 2016-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-08
Pay. Date : 2016-09-29
DMF Number : 30772
Submission : 2016-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32456
Submission : 2017-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-22
Pay. Date : 2015-07-28
DMF Number : 29558
Submission : 2015-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2013-12-09
DMF Number : 27727
Submission : 2013-12-27
Status : Active
Type : II
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