01 2Aurobindo Pharma Limited
02 2Covalent Laboratories Private Limited
03 1Lupin Ltd
04 1Nectar Lifesciences
05 1Olon S.p.A
06 1Orchid Pharma
07 1RANBAXY LABORATORIES LIMITED
08 1Sandoz B2B
09 1TAPI Technology & API Services
10 1TIANJIN GENCOM PHARMACEUTICAL CO LTD
01 2CEFDINIR
02 1CEFDINIR FORM-B
03 2CEFDINIR HYDRATE
04 1CEFDINIR HYDRATE USP
05 1CEFDINIR MONOHYDRATE USP
06 3CEFDINIR USP
07 1CEFDINIR USP (ANHYDROUS)
08 1CEFDINIR USP (CRYSTAL B)
01 1China
02 8India
03 1Israel
04 1Italy
05 1Switzerland
01 11Active
02 1Inactive
01 4Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19607
Submission : 2006-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-07-19
DMF Number : 30320
Submission : 2016-02-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-07
Pay. Date : 2016-10-19
DMF Number : 25882
Submission : 2012-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17705
Submission : 2004-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-05-22
DMF Number : 25570
Submission : 2011-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17986
Submission : 2004-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19401
Submission : 2006-05-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18457
Submission : 2005-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20730
Submission : 2007-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29119
Submission : 2015-02-27
Status : Active
Type : II
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