01 2Aurobindo Pharma Limited
02 1Cipla
03 2Hetero Drugs
04 2Laurus Labs
05 2Lupin Ltd
06 1Olon S.p.A
07 1Signa S.A. de C.V.
08 1Viatris
01 2ABACAVIR SULFATE
02 1ABACAVIR SULFATE (PROCESS-II), USP
03 5ABACAVIR SULFATE USP
04 1ABACAVIR SULFATE USP (PROCESS II)
05 2ABACAVIR SULFATE USP (PROCESS-2)
06 1ABACAVIR SULFATE, USP
01 9India
02 1Italy
03 1Mexico
04 1U.S.A
01 11Active
02 1Inactive
01 10Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-21
DMF Number : 18256
Submission : 2005-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-29
Pay. Date : 2013-03-13
DMF Number : 26299
Submission : 2012-08-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-27
Pay. Date : 2015-12-21
DMF Number : 29587
Submission : 2015-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 22196
Submission : 2008-11-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-27
Pay. Date : 2018-08-23
DMF Number : 33031
Submission : 2018-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-20
Pay. Date : 2014-11-21
DMF Number : 28818
Submission : 2014-12-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-20
DMF Number : 23618
Submission : 2010-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20515
Submission : 2007-05-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-07-07
DMF Number : 23644
Submission : 2010-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-11
DMF Number : 18229
Submission : 2005-03-30
Status : Active
Type : II
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