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FDA Drug Application 021861 by ALCON PHARMS LTD

Application Number021861
Application Type New Drug Application
Sponsor ApplicantALCON PHARMS LTD
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
AP04/15/2008N19689000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021861s000ltr.pdf 4/22/2008
AP04/15/2008N19714000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021861lbl.pdf 4/23/2008
AP04/15/2008N25076000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021861s000TOC.cfm 3/19/2010
AP06/17/2009SE8       
AP012/1/2009SE524163002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021861s002lbl.pdf 12/2/2009
AP012/1/2009SE524620002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021861s002ltr.pdf 1/26/2010
AP03/31/2010SE825191008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021861s008lbl.pdf 4/4/2010
AP03/31/2010SE825215008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021861s008ltr.pdf 4/5/2010
AP02/22/2012SLR31881009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021861s009lbl.pdf 2/24/2012
AP02/22/2012SLR31905009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021861s009ltr.pdf 2/27/2012
AP010/27/2015SLR44322011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021861Orig1s011ltr.pdf 10/28/2015
AP010/27/2015SLR44377011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021861s011lbl.pdf 11/4/2015
AP07/27/2016SCM       
AP09/19/2016SCM       




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