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FDA Drug Application 050804 by BAUSCH AND LOMB

Application Number050804
Application Type New Drug Application
Sponsor ApplicantBAUSCH AND LOMB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/14/2004N10876000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050804ltr.pdf 12/30/2004
AP012/14/2004N10899000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050804lbl.pdf 12/30/2004
AP012/14/2004N11859000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50804_ZyletTOC.cfm 6/23/2005
AP06/3/2010SLR25712015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050804s015lbl.pdf 6/7/2010
AP06/3/2010SLR25718015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050804s015ltr.pdf 6/8/2010
AP010/2/2012SLR33960017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050804Orig1s017ltr.pdf 10/4/2012
AP010/2/2012SLR33968017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050804s017lbl.pdf 10/4/2012
AP02/6/2013SE835099018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050804Orig1s018ltr.pdf 2/8/2013
AP02/6/2013SE835112018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050804s018lbl.pdf 2/8/2013
AP010/9/2013SCM       




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