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FDA Drug Application 022065 by R-PHARM US LLC

Application Number022065
Application Type New Drug Application
Sponsor ApplicantR-PHARM US LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2007N18244000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022065lbl.pdf 10/17/2007
AP010/16/2007N18270000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022065s000ltr.pdf 10/22/2007
AP010/16/2007N19522000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022065TOC.cfm 3/24/2008
AP03/13/2009SCS22007001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s001ltr.pdf 3/17/2009
AP03/13/2009SCS22195001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf 4/3/2009
AP010/2/2009SE823552002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf 10/7/2009
AP010/2/2009SE823556002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf 10/13/2009
AP010/2/2009SLR23557003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf 10/13/2009
AP010/2/2009SLR23553003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf 10/7/2009
AP05/12/2010SLR25552004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf 5/17/2010
AP05/12/2010SLR25564004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf 5/17/2010
AP05/12/2010SLR25565005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf 5/17/2010
AP05/12/2010SLR25553005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf 5/17/2010
AP010/18/2011SE530354006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022065s006ltr.pdf 10/20/2011
AP010/18/2011SE530380006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.pdf 10/20/2011
AP01/20/2015SCM       
AP09/29/2016SLR       




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