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FDA Drug Application 021350 by SKYEPHARMA AG

Application Number021350
Application Type New Drug Application
Sponsor ApplicantSKYEPHARMA AG
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/7/2005N11623000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021350ltr.pdf 5/17/2005
AP05/7/2005N11651000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021350lbl.pdf 5/17/2005
AP05/7/2005N17814000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021350s000TOC.cfm 9/10/2007
AP07/3/2006SLR14424002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021350s002lbl.pdf 7/5/2006
AP07/3/2006SLR14467002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021350s002LTR.pdf 7/13/2006
AP01/15/2008SLR18892005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s005lbl.pdf 1/18/2008
AP01/15/2008SLR18906005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021350s005ltr.pdf 1/18/2008
AP011/17/2008SLR21241008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021350s008ltr.pdf 11/18/2008
AP011/17/2008SLR21245008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s008lbl.pdf 11/19/2008
AP04/19/2012SLR32477010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021350s010lbl.pdf 4/20/2012
AP04/19/2012SLR32502010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021350s010ltr.pdf 4/23/2012
AP01/15/2013SLR34896013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021350Orig1s013ltr.pdf 1/17/2013
AP01/15/2013SLR34919013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021350s013lbl.pdf 1/22/2013
AP04/15/2015SLR42539014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021350s014lbl.pdf 4/16/2015
AP04/15/2015SLR42546014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021350Orig1s014ltr.pdf 4/17/2015
AP011/13/2015SLR44483015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021350Orig1s015ltr.pdf 11/16/2015




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