01 1BASF
02 1SI Group
03 1SMS Pharmaceuticals
04 1Shandong Xinhua Pharmaceutical
05 1Solara Active Pharma Sciences
01 1IBUPROFEN SODIUM
02 3IBUPROFEN SODIUM DIHYDRATE
03 1SODIUM IBUPROFEN DIHYDRATE
01 1China
02 1Germany
03 2India
04 1U.S.A
01 5Active
01 1Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-26
Pay. Date : 2013-11-20
DMF Number : 21587
Submission : 2008-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28403
Submission : 2014-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23755
Submission : 2010-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39473
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23925
Submission : 2010-06-08
Status : Active
Type : II
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