01 1ALP Pharm
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1Curia
04 1Emcure Pharmaceuticals
05 2GLAND PHARMA LIMITED
06 1H. Lundbeck AS
07 1Mitsubishi Tanabe Pharma
08 1ScinoPharm Taiwan, Ltd
09 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 121 S ARGATROBAN
02 4ARGATROBAN
03 1ARGATROBAN HYDRATE
04 1ARGATROBAN MONOHYDRATE (PROCESS-II)
05 1ARGATROBAN MONOHYDRATE USP
06 1ARGATROBAN USP
07 1MCI-9038 ARGATROBAN DRUG SUB.
01 3China
02 1Denmark
03 3India
04 1Japan
05 1Taiwan
06 1U.S.A
01 8Active
02 2Inactive
01 5Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25893
Submission : 2012-02-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-10-25
DMF Number : 20760
Submission : 2007-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25765
Submission : 2012-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-12
Pay. Date : 2013-03-26
DMF Number : 25400
Submission : 2011-10-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-15
Pay. Date : 2014-11-28
DMF Number : 28030
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 21304
Submission : 2008-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7801
Submission : 1988-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22935
Submission : 2009-07-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31131
Submission : 2016-12-05
Status : Active
Type : II
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