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FDA Drug Application 021545 by ALCON PHARMS LTD

Application Number021545
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
AP012/22/2004N10807000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021545ltr.pdf 12/29/2004
AP012/22/2004N10830000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021545lbl.pdf 12/29/2004
AP012/22/2004N15827000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021545s000TOC.cfm 2/20/2007
AP010/4/2006SLR       
AP04/26/2007SLR16347006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s006lbl.pdf 5/1/2007
AP04/26/2007SLR16375006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s006ltr.pdf 5/1/2007
AP06/8/2007SLR16750008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf 6/12/2007
AP06/8/2007SLR16762008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s008, 021545s009ltr.pdf 6/14/2007
AP06/8/2007SCP16751009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf 6/12/2007
AP06/8/2007SCP16763009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s008, 021545s009ltr.pdf 6/14/2007
AP012/8/2010SLR27259013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021545s013lbl.pdf 12/8/2010
AP012/8/2010SLR27264013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021545s013ltr.pdf 12/10/2010
AP010/8/2015SCM       




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