01 1Alkem Laboratories
02 1Cadila Pharmaceuticals
03 1CordenPharma
04 1F.I.S. Fabbrica Italiana Sintetici
05 1HONOUR LAB LTD
06 2Hetero Drugs
07 1Johnson & Johnson Innovative Medicine
08 1MSN Laboratories
09 1Macleods Pharmaceuticals Limited
10 1Nivika Chemo Pharma Pvt. Ltd
11 1Smaart Pharmaceutticals
12 1Torrent Pharmaceuticals Limited
13 1Zhejiang Ausun Pharmaceutical
14 1Zhejiang Huahai Pharmaceutical
01 1NEBIVOLOL HCI
02 11NEBIVOLOL HYDROCHLORIDE
03 1NEBIVOLOL HYDROCHLORIDE (PROCESS-II)
04 1NEBIVOLOL HYDROCHLORIDE [ROUTE CODE: 'NH']
05 1NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS
01 2China
02 1Germany
03 10India
04 1Italy
05 1U.S.A
01 14Active
02 1Inactive
01 10Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2013-09-11
DMF Number : 21152
Submission : 2007-12-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30052
Submission : 2015-12-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-13
Pay. Date : 2014-10-06
DMF Number : 22735
Submission : 2009-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-04
Pay. Date : 2012-12-05
DMF Number : 25296
Submission : 2011-09-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-10-07
DMF Number : 28627
Submission : 2014-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15417
Submission : 2001-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-24
DMF Number : 29996
Submission : 2016-02-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-01
Pay. Date : 2014-11-20
DMF Number : 24916
Submission : 2011-05-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22906
Submission : 2009-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2015-09-21
DMF Number : 29730
Submission : 2015-09-28
Status : Active
Type : II
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