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 1TOPHARMAN SHANDONG CO LTD
08 2Teva API
09 1Viatris
01 11-((2R,3R,4R,5R)-3-FLUORO-4-HYDROXY-5-(HYDROXYMETHYL)-3-METHYLTETRAHYDROFURAN-2-YL) PYRIMIDINE-2,4(1H,3H)-DIONE (SOFOSBUVIR INTERMEDIATE)
02 5SOFOSBUVIR
03 1SOFOSBUVIR (AMORPHOUS)
04 1SOFOSBUVIR 1213
05 1SOFOSBUVIR 1613
06 1SOFOSBUVIR PREMIX
01 4China
02 3India
03 2Israel
04 1U.S.A
01 9Active
02 1Inactive
01 5Complete
02 5Blank
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 29576
Submission : 2015-08-31
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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