Axplora- The partner of choice for complex APIs.
01 1Axplora
02 2Ajinomoto Company
03 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
04 1Corden Pharma Bergamo S.p.A
05 1Formosa Laboratories
06 1Ipca Laboratories
07 1Olon S.p.A
08 1Signa S.A. de C.V.
09 1Blank
01 4BALSALAZIDE DISODIUM
02 3BALSALAZIDE DISODIUM DIHYDRATE
03 2BALSALAZIDE DISODIUM DIHYDRATE USP
04 1BALSALAZIDE DISODIUM SALT
01 1China
02 1Germany
03 1India
04 2Italy
05 2Japan
06 1Mexico
07 1Taiwan
08 1Blank
01 3Active
02 7Inactive
01 3Complete
02 7Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-10
Pay. Date : 2021-08-06
DMF Number : 16425
Submission : 2003-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12287
Submission : 1996-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16256
Submission : 2003-01-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18573
Submission : 2005-05-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17500
Submission : 2004-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-07
Pay. Date : 2013-07-30
DMF Number : 17326
Submission : 2004-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17780
Submission : 2004-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19684
Submission : 2006-08-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-24
Pay. Date : 2013-04-30
DMF Number : 18894
Submission : 2005-10-21
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12289
Submission : 1996-12-18
Status : Inactive
Type : II
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