01 1Corden Pharma Bergamo S.p.A
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 2Emcure Pharmaceuticals
04 1Pfizer Inc
05 1Viatris
01 5OLSALAZINE SODIUM
02 1OLSALAZINE SODIUM (PROCESS II)
01 2India
02 1Italy
03 1Switzerland
04 2U.S.A
01 3Active
02 3Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21981
Submission : 2008-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17677
Submission : 2004-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27618
Submission : 2013-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21633
Submission : 2008-05-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6443
Submission : 1986-06-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39269
Submission : 2023-12-20
Status : Active
Type : II
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