01 1Actavis Inc
02 1Aurobindo Pharma Limited
03 1CEPHALON INC
04 1Lupin Ltd
05 1Orchid Pharma
06 1Piramal Pharma Solutions
07 1SAFC
08 2TAPI Technology & API Services
09 1Unimark Remedies Limited
10 1Viatris
01 7ARMODAFINIL
02 1ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)
03 1ARMODAFINIL 7SM1029
04 2ARMODAFINIL DRUG SUBSTANCE
01 4India
02 1Ireland
03 2Israel
04 4U.S.A
01 9Active
02 2Inactive
01 3Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22983
Submission : 2009-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-24
DMF Number : 27302
Submission : 2013-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19685
Submission : 2006-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23134
Submission : 2009-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 25031
Submission : 2011-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30405
Submission : 2016-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18107
Submission : 2005-02-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30350
Submission : 2016-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-05
Pay. Date : 2014-01-22
DMF Number : 24945
Submission : 2011-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-02
Pay. Date : 2017-04-20
DMF Number : 21200
Submission : 2007-12-19
Status : Active
Type : II
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