01 1Divis Laboratories
02 1Glenmark Life Sciences
03 1Hetero Drugs
04 1Ipca Laboratories
05 1Jacobus Pharmaceutical Company, Inc
06 1National Institutes of Health
07 1Sifavitor srl
08 1Taro Pharmaceutical Industries
09 1Viatris
10 1Zydus Lifesciences
01 1PALUDRINE
02 3PROGUANIL HYDROCHLORIDE
03 5PROGUANIL HYDROCHLORIDE USP
04 1PROGUANIL HYDROCHLORIDE, USP
01 5India
02 1Italy
03 4U.S.A
01 6Active
02 4Inactive
01 4Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-12-08
DMF Number : 18065
Submission : 2005-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32644
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-05
Pay. Date : 2017-08-09
DMF Number : 24998
Submission : 2011-05-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-30
DMF Number : 21475
Submission : 2008-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13857
Submission : 1998-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34
Submission : 1946-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23270
Submission : 2009-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-23
Pay. Date : 2014-02-28
DMF Number : 26103
Submission : 2012-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22059
Submission : 2008-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21461
Submission : 2008-03-26
Status : Inactive
Type : II
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