01 1Aurobindo Pharma Limited
02 1CTX Lifesciences
03 1Emcure Pharmaceuticals
04 2Formosa Laboratories
05 1Ind Swift Laboratories Limited
06 1Lupin Ltd
07 1Navinta
08 1Royal DSM
09 1Solara Active Pharma Sciences
10 1Waterstone Pharmaceuticals Inc.
01 11COLESEVELAM HYDROCHLORIDE
01 1China
02 6India
03 1Netherlands
04 2Taiwan
05 1U.S.A
01 8Active
02 3Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-30
Pay. Date : 2016-10-28
DMF Number : 31095
Submission : 2016-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-12-05
DMF Number : 26934
Submission : 2013-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-13
Pay. Date : 2015-11-16
DMF Number : 30001
Submission : 2015-11-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-01
Pay. Date : 2013-04-18
DMF Number : 22870
Submission : 2009-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26813
Submission : 2013-02-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23333
Submission : 2010-04-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38605
Submission : 2023-07-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-04
Pay. Date : 2015-01-14
DMF Number : 28945
Submission : 2014-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-20
DMF Number : 23378
Submission : 2009-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37431
Submission : 2022-12-22
Status : Active
Type : II
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