01 2Bayer AG
02 1Corden Pharma Bergamo S.p.A
03 1Divis Laboratories
04 1Fine Organics
05 1SALSBURY CHEMICALS INC
06 1Shanghai Ziyuan Pharmaceutical
07 1Solara Active Pharma Sciences
08 2Zhejiang Jiuzhou Pharmaceutical
09 2Blank
01 1SALAZOSULFAPYRIDINE
02 1SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT
03 4SULFASALAZINE
04 1SULFASALAZINE PVP
05 1SULFASALAZINE STARCH POWDER
06 1SULFASALAZINE-PVP
07 3SULPHAZINE
01 3China
02 2Germany
03 2India
04 1Italy
05 1U.S.A
06 1United Kingdom
07 2Blank
01 1Active
02 11Inactive
01 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7242
Submission : 1987-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5145
Submission : 1983-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11163
Submission : 1994-10-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16817
Submission : 2003-09-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8886
Submission : 1990-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14688
Submission : 2000-01-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14751
Submission : 2000-03-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14724
Submission : 2000-02-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7127
Submission : 1987-08-17
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 : 6489
Submission : 1986-07-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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