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FDA Drug Application 021304 by HOFFMANN LA ROCHE

Application Number021304
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Priority
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/29/2001N1590000 3/29/2001
AP03/29/2001N1591000 3/29/2001
AP03/29/2001N8326000 4/12/2004
AP09/12/2003SE16659001 9/25/2003
AP09/12/2003SE16675001 9/25/2003
AP09/12/2003SE118502001 11/19/2007
AP01/31/2006SLR13575004 2/2/2006
AP01/31/2006SLR13581004 2/2/2006
AP08/28/2009SLR23257007,022257s000lbl.pdf 8/30/2009
AP08/28/2009SLR23266007 9/1/2009
AP08/28/2009SLR25632007 hydrochloride_toc.cfm 5/27/2010
AP08/28/2009SLR25633007 5/27/2010
AP08/5/2010SE226160008,022257s003ltr.pdf 8/10/2010
AP08/5/2010SE226173008,022257s003lbl.pdf 8/10/2010
AP03/28/2013SLR35582010,022257Orig1s004ltr.pdf 4/1/2013
AP03/28/2013SLR35619010,022257s004lbl.pdf 4/1/2013
AP04/23/2015SE842647011,022257Orig1s005ltr.pdf 4/24/2015
AP04/23/2015SE842676011,021304s011lbl.pdf 4/28/2015

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