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01 1Ami Lifesciences Private Limited
02 1Apothecon Pharmaceuticals
03 1Aurobindo Pharma Limited
04 2CHEMO IBERICA SA
05 1CTX Lifesciences
06 3Emcure Pharmaceuticals
07 2Formosa Laboratories
08 2Hetero Drugs
09 1Lupin Ltd
10 1Shandong Xinhua Pharmaceutical
11 1Solara Active Pharma Sciences
12 1Sun Pharmaceutical Industries Limited
13 1Viatris
14 1Waterstone Pharmaceuticals Inc.
01 16SEVELAMER CARBONATE
02 1SEVELAMER CARBONATE (E SUB)
03 1SEVELAMER CARBONATE (FOR POWDER FORMULATION)
04 1SEVELAMER CARBONATE (PROCESS II)
01 2China
02 12India
03 2Spain
04 2Taiwan
05 1U.S.A
01 14Active
02 5Inactive
01 8Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37981
Submission : 2023-01-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2014-01-02
DMF Number : 27405
Submission : 2014-01-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-13
Pay. Date : 2014-02-07
DMF Number : 27926
Submission : 2014-02-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-09-18
DMF Number : 25039
Submission : 2011-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23459
Submission : 2010-01-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-21
Pay. Date : 2012-11-23
DMF Number : 23039
Submission : 2009-08-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-26
DMF Number : 22293
Submission : 2008-12-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-09-25
DMF Number : 22940
Submission : 2009-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24587
Submission : 2011-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25639
Submission : 2011-12-29
Status : Active
Type : II
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