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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   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf 8/30/2009
AP08/28/2009N23265000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf 9/1/2009
AP08/28/2009N25630000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_valganciclovir hydrochloride_toc.cfm 5/27/2010
AP08/28/2009N25631000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-1_021304s007sumr.pdf 5/27/2010
AP08/5/2010SLR26161003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003ltr.pdf 8/10/2010
AP08/5/2010SLR26172003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf 8/10/2010
AP03/28/2013SLR35583004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021304Orig1s010,022257Orig1s004ltr.pdf 4/1/2013
AP03/28/2013SLR35618004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf 4/1/2013
AP04/23/2015SE842646005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf 4/24/2015
AP04/23/2015SE842677005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf 4/28/2015
AP07/14/2015SCM       




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