01 1ACS DOBFAR SPA
02 1Antibioticos do Brasil Ltda
03 1Aurobindo Pharma Limited
04 1Nectar Lifesciences
05 1Qilu Antibiotics Pharmaceutical Co., Ltd.
06 1Sandoz B2B
01 1CEFEPIME FOR INJECTION
02 1CEFEPIME FOR INJECTION (STERILE BULK)
03 2CEFEPIME FOR INJECTION USP (STERILE BULK)
04 1CEFEPIME FOR INJECTION USP (STERILE BULK) DRUG SUBSTANCE
05 1Cefepime, unsterile
01 1Brazil
02 1China
03 2India
04 1Italy
05 1Switzerland
01 4Active
02 2Inactive
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-15
Pay. Date : 2016-07-05
DMF Number : 24395
Submission : 2011-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-14
DMF Number : 19806
Submission : 2006-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19755
Submission : 2006-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25913
Submission : 2012-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-17
Pay. Date : 2013-08-07
DMF Number : 25303
Submission : 2011-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21139
Submission : 2007-12-14
Status : Inactive
Type : II
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