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FDA Drug Application 022007 by MYLAN SPECLT

Application Number022007
Application Type New Drug Application
Sponsor ApplicantMYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA04/27/2007TA16369000 5/1/2007
AP15/11/2007N16369000 5/1/2007
TA04/27/2007TA16661000 5/31/2007
AP15/11/2007N16661000 5/31/2007
TA04/27/2007TA19553000 3/28/2008
AP15/11/2007N19553000 3/28/2008
TA04/27/2007TA19554000 4/1/2008
AP15/11/2007N19554000 4/1/2008
TA04/27/2007TA22044000 3/19/2009
AP15/11/2007N22044000 3/19/2009
TA04/27/2007TA27999000REMS 3/1/2011
AP15/11/2007N27999000REMS 3/1/2011
TA04/27/2007TA25704000 6/4/2010
AP15/11/2007N25704000 6/4/2010
AP06/2/2010SLR25668004 6/2/2010
AP06/2/2010SLR25679004 6/3/2010
AP02/1/2011SLR27756005 2/7/2011
AP01/11/2012SLR31390006 1/17/2012
AP01/11/2012SLR31478006 1/23/2012
AP09/25/2012SLR33926007,s008ltr.pdf 10/2/2012
AP09/25/2012SLR33927008,s008ltr.pdf 10/2/2012

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