01 1Amino Chemicals
02 1Apotex Pharmachem
03 1Aurobindo Pharma Limited
04 1Centaur Pharmaceuticals
05 1Cipla
06 1Gador SA
07 1Orchid Pharma
08 1TAPI Technology & API Services
09 1Zydus Lifesciences
01 7ZALEPLON
02 2ZALEPLON USP
01 1Argentina
02 1Canada
03 5India
04 1Israel
05 1Malta
01 4Active
02 5Inactive
01 1Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16785
Submission : 2003-08-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22572
Submission : 2009-02-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19398
Submission : 2006-04-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2013-09-25
DMF Number : 27568
Submission : 2013-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18022
Submission : 2005-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19015
Submission : 2005-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20877
Submission : 2007-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17565
Submission : 2004-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21482
Submission : 2008-04-01
Status : Inactive
Type : II
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