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FDA Drug Application 021372 by HELSINN HLTHCARE

Application Number021372
Application Type New Drug Application
Sponsor ApplicantHELSINN HLTHCARE
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
AP07/25/2003N6403000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21372ltr.pdf 8/6/2003
AP07/25/2003N6404000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21372_aloxi_lbl.pdf 8/6/2003
AP07/25/2003N7567000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-372_Alox.cfm 1/15/2004
AP07/5/2005SLR11940002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021372s002lbl.pdf 7/7/2005
AP07/5/2005SLR11956002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021372s002ltr.pdf 7/8/2005
AP08/23/2006SLR14765005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021372s005lbl.pdf 8/29/2006
AP08/23/2006SLR14889005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021372s005ltr.pdf 9/18/2006
AP08/30/2007SE217739006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021372s006lbl.pdf 9/4/2007
AP08/30/2007SE217743006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021372s006ltr.pdf 9/4/2007
AP02/29/2008SE119364008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf 3/5/2008
AP02/29/2008SE119380008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021372s008, s010ltr.pdf 3/5/2008
AP02/29/2008SE124285008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm 12/12/2009
AP02/29/2008SE124287008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf 12/12/2009
AP02/29/2008SE819365010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf 3/5/2008
AP02/29/2008SE819381010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021372s008, s010ltr.pdf 3/5/2008
AP02/29/2008SE824286010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm 12/12/2009
AP02/29/2008SE824288010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf 12/12/2009
AP02/6/2014SLR38476017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s017lbl.pdf 2/7/2014
AP02/6/2014SLR38492017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s017ltr.pdf 2/11/2014
AP05/27/2014SE839411018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s018,s019ltr.pdf 6/2/2014
AP05/27/2014SE839370019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s018s019lbl.pdf 5/28/2014
AP05/27/2014SE839412019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s018,s019ltr.pdf 6/2/2014
AP09/18/2014SLR40534020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf 9/22/2014
AP09/18/2014SLR40560020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s020ltr.pdf 9/23/2014




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