01 1Apotex Pharmachem
02 2Hetero Drugs
03 1Johnson & Johnson Innovative Medicine
04 1MSN Laboratories
05 1Viatris
01 3ETRAVIRINE
02 1ETRAVIRINE (R165335) DRUG SUBSTANCE
03 1ETRAVIRINE PREMIX
04 1ETRAVIRINE [ROUTE CODE "EV"]
01 1Canada
02 3India
03 2U.S.A
01 5Active
02 1Inactive
01 4Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27923
Submission : 2014-03-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-20
Pay. Date : 2021-06-17
DMF Number : 35835
Submission : 2021-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-22
Pay. Date : 2014-05-15
DMF Number : 25550
Submission : 2011-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20440
Submission : 2007-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-13
Pay. Date : 2019-01-28
DMF Number : 29404
Submission : 2015-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-07
Pay. Date : 2014-11-25
DMF Number : 28813
Submission : 2014-12-22
Status : Active
Type : II
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