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FDA Drug Application 021777 by IVAX INTL

Application Number021777
Application Type New Drug Application
Sponsor ApplicantIVAX INTL
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
AP02/1/2007N15743000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021777lbl.pdf 2/2/2007
AP02/1/2007N15793000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021777s000ltr.pdf 2/12/2007
AP02/1/2007N19771000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021777s000TOC.cfm 5/6/2008
AP03/24/2008SLR19533003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021777s003ltr.pdf 3/26/2008
AP06/7/2013SLR36266006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777Orig1s006,s009ltr.pdf 6/11/2013
AP06/7/2013SLR36262006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s006s009lbl.pdf 6/11/2013
AP06/7/2013SLR36263009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777Orig1s006s009lbl.pdf 6/11/2013
AP06/7/2013SLR36268009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777s006,s009ltr.pdf 6/11/2013
AP04/11/2013SLR35694012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777Orig1s012ltr.pdf 4/16/2013
AP04/11/2013SLR35729012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s012lbl.pdf 4/16/2013
AP03/24/2016SCM       
AP05/25/2016SLR46183014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021777Orig1s014ltr.pdf 5/27/2016
AP05/25/2016SLR46216014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021777s014lbl.pdf 6/1/2016




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