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FDA Drug Application 022181 by BIOMARIN PHARM

Application Number022181
Application Type New Drug Application
Sponsor ApplicantBIOMARIN PHARM
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
AP012/13/2007N18645000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022181lbl.pdf 12/13/2007
AP012/13/2007N18646000   http://www.fda.gov/cder/drug/infopage/sapropterin/qa.htm 12/13/2007
AP012/13/2007N18647000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022181s000_ltr.pdf 12/13/2007
AP012/13/2007N19521000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181TOC.cfm 3/24/2008
AP012/13/2007N20264000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181s000_SumR.pdf 7/22/2008
AP06/20/2008SCP20072001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022181s001ltr.pdf 6/24/2008
AP01/23/2013SCM       
AP012/19/2013SCM38126009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s009ltr.pdf 12/20/2013
AP012/19/2013SCM38148009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s009lbl.pdf 12/23/2013
AP012/19/2013SE838149010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s010lbl.pdf 12/23/2013
AP012/19/2013SE838125010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s010ltr.pdf 12/20/2013
AP011/22/2013SCM       
AP04/23/2014SE839126013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022181Orig1s013ltr.pdf 4/24/2014
AP04/23/2014SE844436013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022181s013lbl.pdf 11/10/2015
AP06/13/2016SLR46331014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022181Orig1s014ltr.pdf 6/15/2016
AP06/13/2016SLR46352014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022181s014lbl.pdf 6/17/2016




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