01 1Apotex Pharmachem
02 1Aurobindo Pharma Limited
03 1F.I.S. Fabbrica Italiana Sintetici
04 1Hetero Drugs
05 1Optimus Pharma
06 1Teva API
07 1Tianjin Weijie Pharmaceutical Co., Ltd.
08 2Viatris
09 1Viwit Pharmaceuticals Limited
10 1Yung Shin Pharmaceutical Industrial
01 1(R)-5-BROMO-3-[(1-METHYL-2-PYRROLIDINYL)METHYL]-1H-INDOLE (ELETRIPTAN INTERMEDIATE)
02 6ELETRIPTAN HYDROBROMIDE
03 1ELETRIPTAN HYDROBROMIDE "YUNG SHIN"
04 1ELETRIPTAN HYDROBROMIDE (DRUG SUBSTANCE, NON-STERILE)
05 1ELETRIPTAN HYDROBROMIDE (PROCESS 1)
06 1ELETRIPTAN HYDROBROMIDE (PROCESS 2)
01 1Canada
02 3China
03 3India
04 1Israel
05 1Italy
06 2U.S.A
01 9Active
02 2Inactive
01 5Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23651
Submission : 2010-03-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-28
Pay. Date : 2017-01-19
DMF Number : 31336
Submission : 2017-01-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-18
Pay. Date : 2013-10-25
DMF Number : 24528
Submission : 2010-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-12
Pay. Date : 2012-12-14
DMF Number : 26099
Submission : 2012-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29890
Submission : 2015-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22912
Submission : 2009-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30338
Submission : 2016-03-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25076
Submission : 2011-06-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-20
Pay. Date : 2012-11-07
DMF Number : 24504
Submission : 2010-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-10
Pay. Date : 2015-09-25
DMF Number : 29616
Submission : 2015-09-24
Status : Active
Type : II
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