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FDA Drug Application 022257 by HOFFMANN LA ROCHE

Application Number022257
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/28/2009N23256000,022257s000lbl.pdf 8/30/2009
AP08/28/2009N23265000 9/1/2009
AP08/28/2009N25630000 hydrochloride_toc.cfm 5/27/2010
AP08/28/2009N25631000 5/27/2010
AP08/5/2010SLR26161003,022257s003ltr.pdf 8/10/2010
AP08/5/2010SLR26172003,022257s003lbl.pdf 8/10/2010
AP03/28/2013SLR35583004,022257Orig1s004ltr.pdf 4/1/2013
AP03/28/2013SLR35618004,022257s004lbl.pdf 4/1/2013
AP04/23/2015SE842646005,022257Orig1s005ltr.pdf 4/24/2015
AP04/23/2015SE842677005,021304s011lbl.pdf 4/28/2015

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