01 1Akums Lifesciences
02 1Astellas Pharma
03 1Aurobindo Pharma Limited
04 1CSPC Pharmaceutical Group
05 1Covalent Laboratories Private Limited
06 1Kyongbo Pharmaceutical Co., Ltd
07 1Lupin Ltd
08 1Nectar Lifesciences
09 2Orchid Pharma
10 1Pfizer Inc
11 1Qilu Antibiotics Pharmaceutical Co., Ltd.
12 2Sandoz B2B
13 1Unimark Remedies Limited
01 6CEFIXIME
02 1CEFIXIME (PROCESS 2)
03 1CEFIXIME BULK
04 1CEFIXIME NON-STERILE
05 4CEFIXIME USP
06 1CEFIXIME USP (NON-STERILE DRUG SUBSTANCE)
07 1CEFIXIME, USP
01 2China
02 8India
03 1Japan
04 1South Korea
05 2Switzerland
06 1U.S.A
01 9Active
02 6Inactive
01 7Complete
02 8Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-29
Pay. Date : 2014-02-25
DMF Number : 23474
Submission : 2010-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9478
Submission : 1991-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-09-13
DMF Number : 26369
Submission : 2012-09-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-28
Pay. Date : 2016-10-19
DMF Number : 27121
Submission : 2013-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15996
Submission : 2002-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2012-12-17
DMF Number : 19307
Submission : 2006-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19960
Submission : 2006-11-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-11-28
Pay. Date : 2022-08-19
DMF Number : 36694
Submission : 2022-07-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-27
Pay. Date : 2013-09-19
DMF Number : 27527
Submission : 2013-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-09-27
DMF Number : 26047
Submission : 2012-06-08
Status : Active
Type : II
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