01 2ACS DOBFAR SPA
02 1Fresenius Kabi Anti-Infectives
03 2Lupin Ltd
04 2Nectar Lifesciences
05 2Orchid Pharma
01 1CEFEPIME HCI USP
02 1CEFEPIME HYDROCHLORIDE (NON-STERILE)
03 1CEFEPIME HYDROCHLORIDE (STERILE BULK)
04 1CEFEPIME HYDROCHLORIDE ORAL GRADE
05 1CEFEPIME HYDROCHLORIDE STERILE
06 1CEFEPIME HYDROCHLORIDE USP (STERILE)
07 1CRUDE CEFEPIME HYDROCHLORIDE
08 1STERILE CEFEPIME HYDROCHLORIDE (BUFFERED)
09 1STERILE CEFEPIME HYDROCHLORIDE USP
01 6India
02 3Italy
01 7Active
02 2Inactive
01 1Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19927
Submission : 2006-11-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19798
Submission : 2006-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-01
Pay. Date : 2014-03-04
DMF Number : 27971
Submission : 2014-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20265
Submission : 2007-02-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20260
Submission : 2007-02-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25017
Submission : 2011-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25016
Submission : 2012-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18902
Submission : 2005-10-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25443
Submission : 2011-11-28
Status : Active
Type : II
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