01 1ACS DOBFAR SPA
02 1Akums Lifesciences
03 1Aurobindo Pharma Limited
04 1Covalent Laboratories Private Limited
05 1Hetero Drugs
06 1Lupin Ltd
07 2Orchid Pharma
08 1Qilu Antibiotics Pharmaceutical Co., Ltd.
09 1RANBAXY LABORATORIES LIMITED
10 1Sandoz B2B
11 1TAPI Technology & API Services
12 1Unimark Remedies Limited
01 5CEFPROZIL
02 1CEFPROZIL (PROCESS-2)
03 1CEFPROZIL MONOHYDRATE
04 5CEFPROZIL USP
05 1CEFPROZIL USP (NON-STERILE BULK)
01 1China
02 9India
03 1Israel
04 1Italy
05 1Switzerland
01 7Active
02 6Inactive
01 3Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24047
Submission : 2010-08-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-24
Pay. Date : 2014-03-24
DMF Number : 18469
Submission : 2005-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-11
Pay. Date : 2017-05-31
DMF Number : 29383
Submission : 2015-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18434
Submission : 2005-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17731
Submission : 2004-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17375
Submission : 2004-05-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-10
Pay. Date : 2012-12-19
DMF Number : 26699
Submission : 2013-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16973
Submission : 2003-11-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17453
Submission : 2004-06-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17827
Submission : 2004-11-16
Status : Active
Type : II
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