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FDA Drug Application 022428 by ALCON PHARMS LTD

Application Number022428
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
AP011/19/2010N27014000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022428s000ltr.pdf 11/26/2010
AP011/19/2010N27015000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022428s000lbl.pdf 11/26/2010
AP011/19/2010N29040000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428_moxeza_toc.cfm 6/7/2011
AP011/19/2010N29041000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428Orig1s000SumR.pdf 6/7/2011
AP010/18/2011SLR30356001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022428s001ltr.pdf 10/20/2011
AP09/14/2012SLR33781002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022428Orig1s002ltr.pdf 9/18/2012
AP09/14/2012SLR33785002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022428s002lbl.pdf 9/18/2012




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