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FDA Drug Application 050818 by ALCON PHARMS LTD

Application Number050818
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
AP02/13/2009N21863000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050818s000ltr.pdf 2/18/2009
AP02/13/2009N21926000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050818lbl.pdf 3/2/2009
AP02/13/2009N25328000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818_tobradex_st_toc.cfm 4/21/2010
AP02/13/2009N25329000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818s000sumr.pdf 4/21/2010
AP08/3/2010SLR26186001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf 8/10/2010




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