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FDA Drug Application 021425 by BAYER HLTHCARE

Application Number021425
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP09/20/2002N1873000 9/20/2002
AP09/20/2002N1874000 9/20/2002
AP09/20/2002N6015000 6/26/2003
AP01/23/2003SLR9605001 6/29/2004
AP03/12/2004SCP7950006 3/16/2004
AP03/12/2004SCP8225006 4/5/2004
AP08/31/2007SLR17735012 9/4/2007
AP08/31/2007SLR17760012 9/6/2007
AP06/23/2010SE125832017 6/29/2010
AP06/23/2010SE125884017 7/1/2010
AP011/13/2009SCM24554019,021425s019,022090s002ltr.pdf 1/20/2010
AP05/2/2012SLR32642020 5/7/2012
AP07/6/2015SLR43286024,021425s024lbl.pdf 7/9/2015
AP07/6/2015SLR43320024,021425Orig1s024ltr.pdf 7/10/2015

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