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FDA Drug Application 050810 by OAK PHARMS INC

Application Number050810
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/27/2007N16331000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050810lbl.pdf 5/1/2007
AP04/27/2007N16365000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050810s000ltr.pdf 5/1/2007
AP04/27/2007N23164000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050810_azasite_toc.cfm 8/13/2009
AP05/6/2009SLR22514001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf 5/11/2009
AP05/6/2009SCP22515002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf 5/11/2009
AP05/6/2009SLR22516005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf 5/11/2009
AP03/31/2011SLR28433007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050810s007lbl.pdf 4/1/2011
AP03/31/2011SLR28446007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050810s007ltr.pdf 4/4/2011
AP010/16/2012SCM34119012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf 10/17/2012
AP010/16/2012SCM35265012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/050810Orig1s012.pdf 2/27/2013
AP07/5/2012SLR33095014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050810s014ltr.pdf 7/9/2012
AP07/5/2012SLR33115014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s014lbl.pdf 7/10/2012
AP03/12/2013SCM       




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