01 1ALP Pharm
02 1Amoli Organics
03 2Aurobindo Pharma Limited
04 1Chemeca Drugs
05 3Cipla
06 1Exemed Pharmaceuticals
07 3Hetero Drugs
08 1Lee Pharma
09 1Lupin Ltd
10 1PHF SA
11 1RANBAXY LABORATORIES LIMITED
12 1Recordati
13 1Sun Pharmaceutical Industries Limited
14 1Symed Labs
15 1Teva API
16 1Torrent Pharmaceuticals Limited
17 1Viatris
18 2Wanbury Limited
19 1Zydus Lifesciences
01 1SERTRALINE HCL USP (FORM II PROCESS I)
02 5SERTRALINE HYDROCHLORIDE
03 1SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE)
04 1SERTRALINE HYDROCHLORIDE (FORM II)
05 1SERTRALINE HYDROCHLORIDE (FORM-I)
06 1SERTRALINE HYDROCHLORIDE (FORM-I) USP
07 1SERTRALINE HYDROCHLORIDE DRUG SUBSTANCE
08 1SERTRALINE HYDROCHLORIDE DRUG SUBTANCE
09 1SERTRALINE HYDROCHLORIDE FORM I
10 1SERTRALINE HYDROCHLORIDE FORM II
11 1SERTRALINE HYDROCHLORIDE FORM-II
12 4SERTRALINE HYDROCHLORIDE USP
13 1SERTRALINE HYDROCHLORIDE USP (CRYSTALLINE POLYMORPH FORM II)
14 1SERTRALINE HYDROCHLORIDE USP (FORM II)
15 1SERTRALINE HYDROCHLORIDE USP (FORM-V)
16 1SERTRALINE HYDROCHLORIDE USP CRYSTALLINE POLYMORPH FORM I
17 1SERTRALINE HYDROCHLORIDE, USP (FORM 1)
18 1SERTRALINE HYDROCHLORIDE, USP (FORM II), PROCESS II
01 1China
02 20India
03 1Israel
04 1Italy
05 1Switzerland
06 1U.S.A
01 14Active
02 11Inactive
01 7Complete
02 18Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-13
DMF Number : 22652
Submission : 2009-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17435
Submission : 2004-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-29
Pay. Date : 2019-02-14
DMF Number : 33535
Submission : 2019-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25426
Submission : 2011-10-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-01-07
DMF Number : 25238
Submission : 2011-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18239
Submission : 2005-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18311
Submission : 2005-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17325
Submission : 2004-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19931
Submission : 2006-10-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-20
Pay. Date : 2020-07-08
DMF Number : 19035
Submission : 2005-12-13
Status : Active
Type : II
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