01 1ALP Pharm
02 1Alembic Pharmaceuticals Limited
03 2Beijing Hope Pharmaceutical
04 1Cipla
05 1Dipharma
06 1H. Lundbeck AS
07 1Hetero Drugs
08 1Lek Pharmaceuticals
09 1Lupin Ltd
10 2MSN Laboratories
11 1Macleods Pharmaceuticals Limited
12 1Morepen Laboratories
13 1Piramal Pharma Solutions
14 1Raks Pharma
15 1Seasons Biotechnology
16 1Sigmapharm Laboratories, LLC
17 1Symed Labs
18 1Unichem Laboratories Limited
19 1Viatris
20 2Zhejiang Huahai Pharmaceutical
21 1Zydus Lifesciences
01 1LU AA21004 HYDROBROMIDE
02 1VORTIOXETINE HYDROBROMIDE
03 15VORTIOXETINE HYDROBROMIDE
04 1VORTIOXETINE HYDROBROMIDE (FORM-H)
05 1VORTIOXETINE HYDROBROMIDE (FORM-ß)
06 1VORTIOXETINE HYDROBROMIDE AMORPHOUS (24.12%)
07 1VORTIOXETINE HYDROBROMIDE MONOHYDRATE
08 1VORTIOXETINE HYDROBROMIDE PREMIX
09 1VORTIOXETINE HYDROBROMIDE SOLVATE
10 1VORTIOXETINE HYDROBROMIDE [ROUTE CODE "VX"]
01 6China
02 1Denmark
03 12India
04 1Italy
05 1Slovenia
06 3U.S.A
01 24Active
01 16Complete
02 8Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-12-27
DMF Number : 31281
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29849
Submission : 2016-08-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-13
Pay. Date : 2017-02-23
DMF Number : 31389
Submission : 2017-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21224
Submission : 2008-01-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-14
Pay. Date : 2017-03-03
DMF Number : 31314
Submission : 2017-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
Pay. Date : 2017-03-16
DMF Number : 31507
Submission : 2017-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-31
Pay. Date : 2017-05-11
DMF Number : 31411
Submission : 2017-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-03
Pay. Date : 2016-09-29
DMF Number : 30309
Submission : 2016-03-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-24
Pay. Date : 2017-03-27
DMF Number : 31583
Submission : 2017-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-28
Pay. Date : 2017-06-06
DMF Number : 31492
Submission : 2017-05-25
Status : Active
Type : II
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