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FDA Drug Application 202429 by HOFFMANN LA ROCHE

Application Number202429
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/17/2011N29815000 8/17/2011
AP08/17/2011N29816000 8/17/2011
AP08/17/2011N29817000 8/17/2011
AP08/17/2011N29818000 8/17/2011
AP08/17/2011N30386000 10/21/2011
AP08/17/2011N36609000Medication Guide 7/26/2013
AP07/3/2013SLR36465002 7/5/2013
AP07/3/2013SLR36453002,s003ltr.pdf 7/5/2013
AP07/3/2013SLR36454003,s003ltr.pdf 7/5/2013
AP07/3/2013SLR36466003 7/5/2013
AP03/19/2014SE838854004 3/20/2014
AP03/19/2014SE838856004 3/20/2014
AP02/6/2014SLR38477005 2/7/2014
AP02/6/2014SLR38493005 2/11/2014
AP011/25/2014SLR41103006 11/28/2014
AP011/25/2014SLR41140006 12/3/2014
AP08/11/2015SLR43630008 8/12/2015
AP08/11/2015SLR43634008 8/12/2015
AP08/31/2016SE846936009 9/1/2016
AP08/31/2016SE846948009 9/2/2016
AP05/9/2016SLR45908010 5/11/2016
AP05/9/2016SLR45993010 5/11/2016

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