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FDA Drug Application 022575 by SHIRE HUMAN GENETIC

Application Number022575
Application Type New Drug Application
Sponsor ApplicantSHIRE HUMAN GENETIC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/26/2010N24907000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022575lbl.pdf 3/2/2010
AP02/26/2010N24952000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022575s000ltr.pdf 3/4/2010
AP02/26/2010N26101000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022575s000TOC.cfm 8/4/2010
AP03/26/2013SLR35555007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s007,s009ltr.pdf 3/28/2013
AP03/26/2013SLR35594007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf 4/1/2013
AP02/11/2014SCM       
AP03/26/2013SLR35595009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf 4/1/2013
AP07/11/2014SCM       
AP06/3/2013SCM       
AP011/21/2013SE837883012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s012lbl.pdf 11/22/2013
AP011/21/2013SE837905012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s012ltr.pdf 11/25/2013
AP010/2/2013SLR37321013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s013ltr.pdf 10/4/2013
AP010/2/2013SLR37389013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s013lbl.pdf 10/8/2013
AP06/18/2014SCM       
AP012/2/2014SCM       
AP02/3/2015SCM       
AP05/5/2015SLR42744017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022575s017lbl.pdf 5/6/2015
AP05/5/2015SLR42761017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022575Orig1s017ltr.pdf 5/11/2015
AP01/11/2016SCM       




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