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FDA Drug Application 202514 by OAK PHARMS INC

Application Number202514
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/10/2012N31757000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202514s000lbl.pdf 2/13/2012
AP02/10/2012N31759000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202514s000ltr.pdf 2/14/2012
AP02/10/2012N32101000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202514s000TOC.cfm 3/13/2012
AP02/22/2013SLR35239001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202514Orig1s001ltr.pdf 2/26/2013
AP02/22/2013SLR35252001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf 2/26/2013
AP08/28/2013SCM       
AP09/4/2015SCM43939003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf 9/22/2015
AP09/4/2015SCM43831003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf 9/8/2015
AP09/4/2015SLR43832004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf 9/8/2015
AP09/4/2015SLR43940004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf 9/22/2015




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