01 1Angelini Pharma
02 1Emcure Pharmaceuticals
03 1Ind Swift Laboratories Limited
04 1Merck Sante SAS
05 2Olon S.p.A
06 1Wuhan Wuyao Pharmaceutical
07 1Blank
01 3ACAMPROSATE CALCIUM
02 2ACAMPROSATE CALCIUM USP
03 1ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE
04 1CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE
05 1HOMOTAURINE (CALCIUM ACAMPROSATE INTERMEDIATE)
01 1China
02 1France
03 2India
04 3Italy
05 1Blank
01 5Active
02 3Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21348
Submission : 2008-02-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2014-01-22
DMF Number : 25809
Submission : 2012-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 21481
Submission : 2008-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11995
Submission : 1996-06-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21807
Submission : 2008-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2015-09-18
DMF Number : 22625
Submission : 2009-03-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23973
Submission : 2010-08-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15819
Submission : 2002-01-23
Status : Inactive
Type : II
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