01 2ACS DOBFAR SPA
02 1Aurobindo Pharma Limited
03 1Fresenius Kabi Anti-Infectives
04 2Lupin Ltd
05 2Nectar Lifesciences
06 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 1CEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCE
08 1CRUDE CEFEPIME HYDROCHLORIDE
09 1STERILE CEFEPIME HYDROCHLORIDE (BUFFERED)
10 1STERILE CEFEPIME HYDROCHLORIDE USP
01 7India
02 3Italy
01 7Active
02 3Inactive
01 1Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19798
Submission : 2006-09-26
Status : Active
Type : II
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 : 19478
Submission : 2006-05-26
Status : Inactive
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 : 25443
Submission : 2011-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18902
Submission : 2005-10-24
Status : Active
Type : II
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