01 1ACS DOBFAR SPA
02 1Auronext Pharma Private Limited
03 1Hospira, Inc.
04 1RANBAXY LABORATORIES LIMITED
05 1Sandoz B2B
06 1Unimark Remedies Limited
01 1CILASTATIN SODIUM (STERILE BULK)
02 1CILASTATIN SODIUM (STERILE)
03 1CILASTATIN SODIUM STERILE
04 3CILASTATIN SODIUM USP (STERILE)
01 3India
02 1Italy
03 1Switzerland
04 1U.S.A
01 2Active
02 4Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-20
Pay. Date : 2013-11-04
DMF Number : 21594
Submission : 2008-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28929
Submission : 2015-01-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21698
Submission : 2008-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20089
Submission : 2006-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23307
Submission : 2009-11-24
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-07-10
DMF Number : 28365
Submission : 2014-06-12
Status : Active
Type : II
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