01 1AbbVie Inc
02 1Actavis Inc
03 1Apotex Pharmachem
04 1CKD Bio Corporation
05 2Catalent Pharma Solutions
06 1Concord Biotech
07 2Curia
08 1Fujian Kerui Pharmaceutical Co Ltd
09 1GALENA AS
10 1Hangzhou Zhongmei Huadong Pharmaceutical
11 2North China Pharmaceutical Co., Ltd.
12 1North China Pharmaceutical Huasheng Co Ltd
13 1Ruibang Laboratories
14 1Sandoz B2B
15 4Teva API
16 2Zhejiang Ruibang Laboratories
01 8CYCLOSPORINE
02 1CYCLOSPORINE (NON-STERILE BULK FORM)
03 1CYCLOSPORINE 350507
04 1CYCLOSPORINE CRUDE
05 1CYCLOSPORINE ID: 741310
06 1CYCLOSPORINE ID: 741710
07 1CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.
08 2CYCLOSPORINE USP
09 1CYCLOSPORINE USP (BULK)
10 1CYCLOSPORINE USP, NON-STERILE BULK DRUG SUBSTANCE
11 1CYCLOSPORINE, NON-STERILE BULK, USP
12 1CYCLOSPORINE, USP (BULK, NON-STERILE)
13 1CYCLOSPORINE, USP (NON STERILE BULK)
14 1NEORAL 25 MG AND 100 MG SOFTGELS
15 1SANDIMMUNE 25 MG AND 100 MG SOFTGELS
01 1Canada
02 8China
03 1Czech Republic
04 1India
05 1Ireland
06 4Israel
07 1South Korea
08 1Switzerland
09 5U.S.A
01 14Active
02 9Inactive
01 9Complete
02 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13800
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-11
Pay. Date : 2014-05-08
DMF Number : 13929
Submission : 1999-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12214
Submission : 1996-10-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-05
Pay. Date : 2013-04-08
DMF Number : 23962
Submission : 2010-07-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-16
Pay. Date : 2013-12-02
DMF Number : 12949
Submission : 1998-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-16
Pay. Date : 2013-12-12
DMF Number : 13789
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-03
Pay. Date : 2014-02-19
DMF Number : 18932
Submission : 2005-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13799
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-07
DMF Number : 12932
Submission : 1998-04-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-23
Pay. Date : 2015-01-07
DMF Number : 28512
Submission : 2014-12-03
Status : Active
Type : II
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