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FDA Drug Application 021537 by ALCON PHARMS LTD

Application Number021537
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
AP07/18/2003N6168000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21537ltr.pdf 7/28/2003
AP07/18/2003N11563000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021537_Ciprodex.cfm 5/2/2005
AP05/22/2013SCM43713008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021537Orig1s008.pdf 8/25/2015
AP012/10/2015SLR44761012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021537Orig1s012ltr.pdf 12/14/2015
AP012/10/2015SLR44777012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf 12/15/2015




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