01 1Cambrex Corporation
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 1Dipharma
04 1Kremers Urban Pharmaceuticals
05 4Lunan Pharmaceutical
06 1NORDIC SYNTHESIS AB
07 1Shandong Keyuan Pharmaceutical
08 2Blank
01 1DILUTED ISOSORBIDE MONONITRATE
02 1DILUTED ISOSORBIDE MONONITRATE (60%)
03 1DILUTED ISOSORBIDE MONONITRATE (70%)
04 1DILUTED ISOSORBIDE MONONITRATE (DRUG SUBSTANCE, NON-STERILE)
05 1DILUTED ISOSORBIDE MONONITRATE USP
06 1ISOSORBIDE 5-MONONITRATE (5-ISM)
07 1ISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM)
08 1ISOSORBIDE-2-MONONITRATE
09 1ISOSORBIDE-2-MONONITRATE (2-ISMN)
10 1ISOSORBIDE-5-MONONITRATE
11 1ISOSORBIDE-5-MONONITRATE (5-ISMN)
12 1ISOSORBIDE-5-MONONITRATE/LACTOSE
01 5China
02 1Italy
03 1Sweden
04 1Switzerland
05 2U.S.A
06 2Blank
01 5Active
02 7Inactive
01 3Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12679
Submission : 1997-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-15
Pay. Date : 2012-12-24
DMF Number : 6778
Submission : 1987-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6789
Submission : 1987-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6362
Submission : 1984-10-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-22
Pay. Date : 2018-11-26
DMF Number : 29555
Submission : 2015-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23217
Submission : 2009-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-12-24
DMF Number : 23216
Submission : 2009-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5607
Submission : 1984-11-15
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6803
Submission : 1987-02-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6777
Submission : 1987-01-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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