01 1Alembic Pharmaceuticals Limited
02 1Beijing Huikang Boyuan Chemical Tech CO.
03 1Changzhou Pharmaceutical Factory
04 1Fuxin Long Rui Pharmaceutical
05 1Laurus Labs
06 1Lupin Ltd
07 2TAPI Technology & API Services
08 1Viatris
01 5SOFOSBUVIR
02 1SOFOSBUVIR (AMORPHOUS)
03 1SOFOSBUVIR 1213
04 1SOFOSBUVIR 1613
05 1SOFOSBUVIR PREMIX
01 3China
02 3India
03 2Israel
04 1U.S.A
01 8Active
02 1Inactive
01 5Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32075
Submission : 2017-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28919
Submission : 2014-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-24
Pay. Date : 2017-09-15
DMF Number : 32048
Submission : 2017-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33487
Submission : 2019-07-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-15
Pay. Date : 2017-10-23
DMF Number : 32068
Submission : 2017-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31511
Submission : 2017-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-05-25
DMF Number : 31737
Submission : 2017-07-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-05-18
DMF Number : 31736
Submission : 2017-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-08-23
DMF Number : 31272
Submission : 2017-09-01
Status : Active
Type : II
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