01 1Alembic Pharmaceuticals Limited
02 1Beijing Huikang Boyuan Chemical Tech CO.
03 1Bionpharma
04 1Fuxin Long Rui Pharmaceutical
05 1Hetero Drugs
06 1Jiangsu Hengrui Medicine
07 1Maithri Drugs
08 1Servier
09 1Urquima S.A. Grupo Uriach
10 1Zhejiang Liaoyuan Pharmaceutical Co LTD
11 1Zydus Lifesciences
01 9IVABRADINE HYDROCHLORIDE
02 1IVABRADINE HYDROCHLORIDE (FORM IV)
03 1IVABRADINE MONOSULFATE
01 4China
02 1France
03 4India
04 1Spain
05 1U.S.A
01 10Active
02 1Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-12
Pay. Date : 2020-07-22
DMF Number : 32074
Submission : 2017-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28658
Submission : 2014-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-05
Pay. Date : 2018-09-21
DMF Number : 33077
Submission : 2018-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33377
Submission : 2018-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-04
Pay. Date : 2018-12-04
DMF Number : 33368
Submission : 2018-12-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-17
Pay. Date : 2019-03-19
DMF Number : 33246
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27979
Submission : 2014-03-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-01
Pay. Date : 2018-10-19
DMF Number : 33213
Submission : 2018-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32616
Submission : 2019-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-29
Pay. Date : 2018-11-26
DMF Number : 33107
Submission : 2018-10-31
Status : Active
Type : II
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