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FDA Drug Application 021232 by SWEDISH ORPHAN

Application Number021232
Application Type New Drug Application
Sponsor ApplicantSWEDISH ORPHAN
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
AP01/18/2002N3069000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21232ltr.pdf 1/18/2002
AP01/18/2002N3070000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21232lbl.pdf 1/18/2002
AP01/18/2002N3071000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-232_Orfadin.cfm 1/18/2002
AP01/25/2010SLR24716008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021232s008lbl.pdf 2/4/2010
AP01/25/2010SLR24723008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021232s008ltr.pdf 2/5/2010
AP02/13/2013SLR35172010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021232s010lbl.pdf 2/14/2013
AP02/13/2013SLR35177010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021232Orig1s010ltr.pdf 2/15/2013
AP04/2/2013SCM       
AP06/21/2013SCM       
AP05/21/2014SLR39339013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021232Orig1s013ltr.pdf 5/22/2014
AP05/21/2014SLR39391013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021232s013lbl.pdf 5/28/2014
AP010/30/2014SCM       
AP010/27/2014SCM       
AP06/5/2015SCM       
AP06/13/2016SCM46349017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021232s017lbl.pdf 6/17/2016
AP09/21/2016SCM       




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