01 1COSMA S.p.A
02 1China Chemical & Pharmaceutical
03 1Cilag AG
04 1Corden Pharma Bergamo S.p.A
05 1Erregierre SpA
06 1Katwijk Chemie
07 1Olon S.p.A
08 1SIMS Srl
09 1Sumitomo Chemical
10 1Zambon Group SpA
01 8OXAPROZIN
02 1OXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT)
03 1OXAPROZIN JP
01 1China
02 6Italy
03 1Japan
04 1Netherlands
05 1Switzerland
01 3Active
02 7Inactive
01 1Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13119
Submission : 1998-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11867
Submission : 1996-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12340
Submission : 1997-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12999
Submission : 1998-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14059
Submission : 1999-04-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2014-12-29
DMF Number : 11308
Submission : 1995-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12911
Submission : 1998-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15484
Submission : 2001-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11748
Submission : 1995-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13227
Submission : 1998-09-21
Status : Inactive
Type : II
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