01 1Actavis Inc
02 1Alcami
03 1Apotex Pharmachem
04 1Edmond Pharma
05 1Emcure Pharmaceuticals
06 1Enaltec Labs Private Limited
07 1Industriale Chimica
08 1Ipca Laboratories
09 1Nycomed Austria GmbH
10 1Optimus Pharma
11 1Par Pharmaceutical
12 1Tianjin Weijie Pharmaceutical Co., Ltd.
13 2Zydus Lifesciences
01 5MIDODRINE HYDROCHLORIDE
02 1MIDODRINE HYDROCHLORIDE BULK DRUG SUBSTANCE
03 7MIDODRINE HYDROCHLORIDE USP
04 1MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
01 1Austria
02 1Canada
03 1China
04 7India
05 1Ireland
06 1Italy
07 2U.S.A
01 12Active
02 2Inactive
01 7Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16135
Submission : 2002-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16481
Submission : 2003-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18470
Submission : 2005-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-11
Pay. Date : 2018-10-04
DMF Number : 16017
Submission : 2002-06-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-12-08
DMF Number : 30990
Submission : 2016-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2016-09-26
DMF Number : 30806
Submission : 2016-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-29
Pay. Date : 2014-05-12
DMF Number : 16006
Submission : 2002-06-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-16
Pay. Date : 2013-09-25
DMF Number : 27464
Submission : 2013-09-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-01
Pay. Date : 2014-04-29
DMF Number : 28211
Submission : 2014-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30216
Submission : 2016-02-01
Status : Active
Type : II
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