01 1Lupin Ltd
02 1Meiji Seika Pharma
03 1Orchid Pharma
04 1RANBAXY LABORATORIES LIMITED
05 1ZHEJIANG HUAFANG PHARMACEUTICAL CO LTD
01 3CEFDITOREN PIVOXIL
02 2CEFDITOREN PIVOXIL DRUG SUBSTANCE
01 1China
02 3India
03 1Japan
01 2Active
02 3Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23544
Submission : 2010-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17482
Submission : 2004-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20292
Submission : 2007-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19011
Submission : 2005-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25086
Submission : 2011-06-12
Status : Active
Type : II
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